GelPOINT V-Path Transvaginal Access Platform With Retroperitoneal Access Device
The GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device creates an entry route for minimally invasive gynecological instruments. It is inserted through the…
The GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device creates an entry route for minimally invasive gynecological instruments. It is inserted through the vagina to access peritoneal or retroperitoneal spaces while maintaining insufflation. It can also provide a route for removing specimens.
Two Alexis retractors establish the access paths, and a GelSeal cap attaches at the vaginal opening. Sleeves through the cap accept laparoscopic instruments from 5 to 12 millimetres. An endoscope introduced through a sleeve supplies the view of the surgical space.
Listed Item
The GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments and maintain insuffiation during laparoscopic-assisted and vaginal gynecological procedures. The device may be used for sentinel pelvic lymph node dissection occurring in the retroperitoneal space. The device is also a conduit for the extraction of specimens.
Insufflation and Access
The cap provides ports for insufflation and smoke evacuation, with an external insufflator supplying carbon dioxide. The stated use includes sentinel pelvic lymph node dissection in the retroperitoneal space. The platform is supplied sterile for one use.
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tonglu Qianyan Medtech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
Record
| Listed by | Applied Medical Resources Corp., United States |
|---|---|
| FDA product code | HEW |
| Device type | Culdoscope (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1640 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K243152 |
| Record published | 2026-04-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C2R12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GelPOINT V-Path | Applied Medical Resources Corp. | 8 |
| Rumi II Koh-Efficient | Coopersurgical, Inc. | 8 |
| Arch Koh-Efficient | Coopersurgical, Inc. | 8 |
| Culdoscope (And Accessories) | Richard Wolf Gmbh | 5 |
| ColpotomizOR Tube | THE O R Company PTY Ltd | 4 |
| ColpotomizOR Tube System | THE O R Company PTY Ltd | 4 |
| Advincula Delineator™ Uterine Manipulator with 3.5 cm Ultem® Koh-Efficient® | Coopersurgical, Inc. | 4 |
| Advincula Delineator Uterine Manipulator | Coopersurgical, Inc. | 4 |
| Koh Cup | Coopersurgical, Inc. | 3 |
| Ultem Koh Cup | Coopersurgical, Inc. | 3 |
| LiNA McCartney Tube | THE O R Company PTY Ltd | 2 |
| ColpotomizOR Tube | Surgi Supplies International PTY. Ltd. | 2 |
Showing 12 of 24. All products under Culdoscope (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243152 | 2025-10-02 |
| K191294 | 2019-09-06 |
| K143308 | 2015-10-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.