Why the term “uterine manipulator” is not enough
In distributor enquiries, a hospital may request a uterine manipulator without specifying anything else. That sounds clear, but it leaves several practical questions unanswered.
Does the request relate to uterine manipulation and fluid injection during selected laparoscopic gynecologic procedures? Does the workflow also require delineation of the vaginal fornices or vaginal access through a colpotomy or culdotomy incision? Is a uterine cup expected? Does the surgeon want a fixed curved guide rod, adjustable distal angulation, or an adjustable insertion length?
These questions change the configuration. They also change which item number, cup size, operation video and documentation package should be supplied.
Select by workflow and control architecture—not by the product-family name alone.
What is a uterine manipulator?
A uterine manipulator is a gynecologic surgical device used in selected laparoscopic procedures to position or mobilize the uterus according to its intended use and the surgeon's technique.
At a general architecture level, it can be explained as:
The exact construction and intended use vary by device. For the AeroMed HK-WQ-II and HK-ZQ-II product family, the FDA 510(k) summary describes sterile, disposable, single-patient-use devices with a manipulator shaft, an inflatable intrauterine balloon, designated fluid ports and a vaginal sealing balloon in the “II” versions. The same summary distinguishes a curved central guide rod in the WQ family from a guide rod that can be flexed up or down using a handle dial in the ZQ family.
That regulatory description shows why two devices under the same product category can behave differently in the surgeon's hand.
Selection question 1: what workflow is being evaluated?
The first question should be the intended procedure and documented use. The FDA indications associated with K172846 distinguish the WQ and ZQ families. The WQ family is indicated for manipulation of the uterus and injection of fluids during specified laparoscopic gynecologic procedures. The ZQ family is intended for specified laparoscopic procedures in which delineation of the vaginal fornices and vaginal access through a colpotomy or culdotomy incision are desired.
This does not mean that a distributor should make an independent clinical recommendation from a short product description. It means the distributor should identify the requested workflow, then provide the correct controlled documents for clinical and regulatory review.
Selection question 2: is adjustable insertion length required?
Insertion length and distal angulation are different variables.
In AeroMed's current public matrix, HK-WQ-II uses fixed distal angulation with an extensible insertion length of 3.75–11 cm. Its shaft diameter is 6 mm.
After the required length is set, the side locking control secures the selected position. This allows the adjustable-length feature to be demonstrated clearly without suggesting that the distal curve itself changes.
If a buyer asks for an “adjustable manipulator,” the supplier should ask what needs to be adjusted: insertion length or distal angulation?
Selection question 3: is adjustable distal angulation required?
In the same public matrix, HK-ZQ-II uses adjustable distal angulation and length-specific item numbers.
The handle-dial control demonstrates up/down flexion. Working length and shaft diameter are not described as universally adjustable; they are selected from the model matrix.
Current public working-length references are 35, 50, 60, 80 and 100 mm. Shaft diameter is 5 or 6 mm depending on the exact item number. A request for “ZQ” alone is therefore incomplete.
HK-WQ-II vs HK-ZQ-II: two control architectures
| Selection question | HK-WQ-II | HK-ZQ-II |
|---|---|---|
| Distal angulation | Fixed | Adjustable using handle-dial control |
| Insertion / working length | Extensible · 3.75–11 cm | 35 / 50 / 60 / 80 / 100 mm by item number |
| Shaft diameter | 6 mm | 5 or 6 mm by item number |
| Product form | Curved configuration | Flexing / adjustable-angle configuration |
| Main quotation question | Confirm adjustable insertion length is required | Confirm working length, shaft diameter and exact item number |
| Operation video | Demonstrates length adjustment and locking | Demonstrates distal-angle control |
Neither architecture should be presented as universally better. Selection depends on intended workflow, current IFU, surgeon preference, hospital protocol and exact model documentation.
Selection question 4: is a uterine cup part of the request?
A uterine manipulator and a uterine cup are related, but they are not the same purchasing question.
The manipulator can be evaluated independently for its documented uterine manipulation function. A compatible cup may be added for selected workflows, including configurations in which the surgeon needs a cup-based interface for vaginal fornix delineation or colpotomy-related work according to the current IFU.
In the current AeroMed public portfolio, the companion cup has two material and use pathways: UC-P reusable black ceramic and UC-F single-use blue PPS. Both are listed in 30, 35, 40 and 46 mm diameters.
Cup material, use pathway and diameter are configuration variables. A quotation should clearly state whether the request is for a manipulator only or a manipulator plus a compatible uterine cup. Cup selection, assembly, use and—where applicable—reprocessing must follow the current IFU, labeling, surgeon judgment and hospital protocol.
Selection question 5: which item number and documents apply?
The family name is not enough for sample evaluation, quotation or registration work. For HK-WQ-II, the current public reference is UMW2006. For HK-ZQ-II, the public matrix includes six references:
- UMZ2045
- UMZ2055
- UMZ2065
- UMZ2066
- UMZ2086
- UMZ2106
Before shipment, confirm that the item number on the quotation, label, model matrix and supporting documents refers to the same configuration.
Distributor checklist before quotation
- target country and regulatory pathway;
- hospital department and intended procedure;
- adjustable insertion length or adjustable distal angulation;
- working length and shaft diameter;
- exact item number;
- manipulator only or manipulator plus uterine cup;
- cup material and diameter where applicable;
- fluid-injection requirement where applicable;
- current IFU and labeling;
- packaging, sterilization and shelf-life information;
- sample quantity, destination and evaluation timeline.
Regulatory and documentation boundary
The AeroMed HK-WQ and HK-ZQ Uterine Manipulator families are covered by FDA 510(k) K172846, under product code LKF. The official FDA record identifies Beijing HangTian KaDi Technology R&D Institute as the applicant and records a substantially equivalent decision dated June 26, 2018.
This is an FDA 510(k) clearance—not an FDA approval or certification.
The current AeroMed public product page does not present the Uterine Manipulator as CE-marked. Regulatory availability must be confirmed for the destination market before quotation, registration or commercial discussion.
The simplest way to remember the difference
Do not stop at the word “adjustable.” Ask what is adjustable.
HK-WQ-II: adjustable insertion length, fixed distal angulation.
HK-ZQ-II: adjustable distal angulation, working length selected by item number.
Then confirm whether a uterine cup is required, which diameter is requested and which documentation applies in the target market.
Workflow → control architecture → dimensions → cup configuration → exact item number → documentation