GelPOINT V-Path
Transvaginal Access Platform with Insufflation Stabilization System
1manufacturer
8catalogue numbers in this listing
3510(k) clearances naming this product code
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 |
| Record published | 2023-03-17 |
| Record revised | 2023-03-07 (version 3) |
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 |
| Distribution end date | 2026-07-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C2A11 | 11 cm | In distribution |
| C2A15 | 7 cm | In distribution |
| C2A12 | 9.5 cm | In distribution |
| C2A17 | 7 cm | In distribution |
| C2B17 | 7 cm | Withdrawn |
| C2B12 | 9.5 cm | Withdrawn |
| C2B11 | 11 cm | Withdrawn |
| C2B15 | 7 cm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Advincula Delineator™ Uterine Manipulator with 4.0 cm Ultem® Koh-Efficient® | Coopersurgical, Inc. | 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.