Which AeroMed General & MIS product has FDA 510(k) clearance?

AeroMed presents the Specimen Retrieval Bag product family with FDA 510(k) K172789 where applicable. Product scope, labeling, and market-specific documentation should be confirmed before quotation, promotion, or registration submission.

Which products are related to single-port surgery?

Single-port related products include the HK-FDDC Single-Port Access System and its subfamilies such as vNOTES / TaTME platforms, sealing cap, hand-assisted access, and robotic-access configurations. Wound Retractor and Protector products may also be part of access-system workflows depending on the configuration.

Which products are used for access and wound protection?

AeroMed access and wound-protection products include Wound Retractor and Protector, Single-Port Access System, Ring Retractor System, and selected access accessories. Exact configuration should be confirmed against the product page, catalog, and IFU.

Can distributors request General & MIS documentation?

Yes. Qualified distributors can request catalogs, IFU, labeling, model matrices, product images, CE documentation, FDA 510(k) documents where applicable, SFDA documentation where applicable, and quotation support.

Product Domain · General Surgery & Minimally Invasive Surgery

General & MIS Surgery Devices

Q: What products are included in the AeroMed General & MIS Surgery portfolio?

Six families: Specimen Retrieval Bag, Fascial Closure Device, Ring Retractor System, Single-Port Access System, Wound Retractor and Protector, and Articulating Laparoscopic Instruments. The articulating platform is NMPA registered in China and under CE review; current CE marking is not granted.

Access, exposure, specimen retrieval, wound protection, and trocar-site closure product families.

AeroMed Surgical’s General & MIS Surgery portfolio brings together six device families, including the articulating laparoscopic instrument platform under CE review, for laparoscopic, open, single-port, robotic-access, vNOTES / TaTME, wound-protection, and closure workflows. The page is structured for distributors who need to understand how products fit together, which documents to request, and which product families support CE, FDA 510(k), or SFDA pathways where applicable.

CE Documentation FDA 510(k) where applicable SFDA where applicable Distributor Documentation

Established product families

Workflow buckets · Access / Retrieval / Closure

Single-port access subfamily

DOC

Catalog · IFU · certificate support

Quick Answer

What is included in AeroMed General & MIS Surgery?

The established portfolio includes five product families: Specimen Retrieval Bag, Fascial Closure Device, Ring Retractor System, Single-Port Access System, Wound Retractor and Protector.

Access

Single-Port Access and Wound Retractor products support minimally invasive and wound-protection workflows.

Retrieval

Specimen Retrieval Bag supports specimen containment and extraction in laparoscopic / MIS workflows.

Closure

Fascial Closure Device supports trocar-site fascial closure after laparoscopic access.

Exposure

Ring Retractor supports soft-tissue retraction and surgical exposure in open and hybrid cases.

Product Portfolio

Six General & MIS product families.

Five CE-documented families and the articulating laparoscopic instrument platform are shown together. The articulating platform is NMPA registered in China and under CE review.

ARTICULATING INSTRUMENTS

Articulating Laparoscopic Instruments

5.0 mm · 0–60° distal articulation · 360° axial shaft rotation · NMPA

Reusable instrument platform with scissors, needle holders, graspers, and dissectors. CE review is ongoing; current CE marking has not been granted.

RETRIEVAL

Specimen Retrieval Bag

HK-QW Series · Hang T Safe · CE · FDA 510(k) K172789 where applicable

Specimen containment and retrieval product family for laparoscopic / MIS workflows. Public claims should focus on containment and retrieval, with detailed indication and FDA scope confirmed in product-specific documentation.

CLOSURE

Fascial Closure Device

HK-WHQ · 14G / 16G / 17G · CE · SFDA where applicable

Trocar-site fascial closure device family for laparoscopic port-site closure workflows. Available in multiple gauge variants for distributor quotation and hospital evaluation.

EXPOSURE

Ring Retractor System

HK-QK rings + HK-LG hooks · CE

Modular ring retractor and hook system for surgical exposure. The portfolio can be presented by ring size, hook type, and procedure-specific kit configuration.

ACCESS

Single-Port Access System

HK-FDDC · vNOTES / TaTME / robotic / hand-assisted / sealing cap

Single-port access product family for multiple surgical-access workflows. Includes dedicated subpages for sealing cap, hand-assisted, robotic platforms, and vNOTES / TaTME configurations.

AeroMed Wound Retractor and Protector HK-FQ

WOUND PROTECTION

Wound Retractor & Protector

HK-FQ · D / B / Q / Q1 subseries · CE

Wound retractor and protector family for incision protection and access support, including fixed-height, variable-height, skirted, and cesarean-specific configurations.

Workflow Logic

Explain the Portfolio by Surgical Workflow.

For distributors, this page should do more than list products. It should show how each device family fits into a General & MIS operating-room pathway.

Access

Create or protect access

Products that help create the access route or protect the incision during open, laparoscopic, or single-port workflows.

• Single-Port Access System
• Wound Retractor & Protector

Exposure

Maintain surgical field exposure

Products that help retract soft tissue and maintain working space for open or hybrid procedures.

• Ring Retractor System
• Hook and ring kit configurations

Specimen Retrieval

Contain and retrieve

Specimen retrieval products used after resection in documented laparoscopic and MIS workflows.

• Specimen Retrieval Bag

Closure

Close trocar-site fascia

Products used after laparoscopic access to support trocar-site fascial closure workflows.

• Fascial Closure Device
• HK-WHQ 14G / 16G / 17G

Product Matrix

General & MIS Product Matrix.

This matrix helps distributors quickly understand product role, regulatory wording, and how to request the right documents.

Product Family	Main Model / Series	Primary Workflow	Public Regulatory Wording	Recommended Page Role
Specimen Retrieval Bag	HK-QW / Hang T Safe	Specimen containment and retrieval	CE · FDA 510(k) K172789 where applicable	Keep as FDA-supported flagship within General & MIS; avoid overclaiming clinical risk reduction.
Fascial Closure Device	HK-WHQ · 14G / 16G / 17G	Trocar-site fascial closure	CE · SFDA where applicable	Present as a practical laparoscopic closure product with model selection.
Ring Retractor System	HK-QK rings + HK-LG hooks	Soft-tissue retraction and surgical exposure	CE documentation available	Explain by ring / hook / kit configuration instead of “universal procedure coverage.”
Single-Port Access System	HK-FDDC	Single-port access, sealing, robotic-access, hand-assisted, vNOTES / TaTME	CE documentation available	Use as the main internal hub linking sealing cap, hand-assisted, robotic, and vNOTES / TaTME pages.
Wound Retractor & Protector	HK-FQ · D / B / Q / Q1	Incision protection and access support	CE documentation available	Present subseries clearly; avoid compressing 60+ SKUs into one vague product line.

Regulatory wording correction

Use FDA 510(k) where applicable only for product families where the scope is confirmed, and use SFDA where applicable rather than “active in Saudi Arabia” unless you want to make a commercial-market claim. Public pages should guide distributors to request the current document package.

Regulatory & Documentation

Clear Documentation Pathway for Distributors.

The page should build trust without mixing every regulatory status into every product card.

CE documentation is available according to product family, model scope, and current certificate status.

FDA

Use FDA 510(k) K172789 for the Specimen Retrieval Bag where applicable. Do not apply FDA wording to the whole category.

SFDA

Use SFDA documentation where applicable for specific product families and markets.

Distributor files

Catalog, IFU, labels, model matrix, product photos, and quotation support can be provided to qualified partners.

General & MIS Surgery Suite Catalog

Specimen Retrieval Bag · Fascial Closure · Ring Retractor · Single-Port Access · Wound Retractor.

Download Suite Catalog Request Documents

FAQ

Common Questions on AeroMed General & MIS Surgery.

What products are included in the General & MIS portfolio?

It includes six product families: Specimen Retrieval Bag, Fascial Closure Device, Ring Retractor System, Single-Port Access System, Wound Retractor and Protector, and Articulating Laparoscopic Instruments. The articulating platform is under CE review.

Which products are related to single-port access?

The Single-Port Access System is the main single-port product family, with subpages for sealing cap, hand-assisted access, robotic platforms, and vNOTES / TaTME configurations. Some workflows also use Wound Retractor and Protector products.

Which product has FDA 510(k) clearance?

AeroMed presents the Specimen Retrieval Bag product family with FDA 510(k) K172789 where applicable. Distributors should confirm exact model scope and labeling before quotation or market submission.

Which products have SFDA documentation?

SFDA documentation may apply to specific product families and markets. For public pages, the safer wording is “SFDA where applicable” and distributors should request the current market-specific documentation package.

Can distributors request a full General & MIS catalog?

Yes. Qualified distributors can request the General & MIS Surgery Suite Catalog, product images, IFU, labels, regulatory documents, and quotation support.