ColpoWave Colpotomizer
The ColpoWave Colpotomizer is a cup-shaped surgical component used with the CerviGrip uterine manipulator during laparoscopic procedures. It helps the surgeon identify the vaginal fornices…
The ColpoWave Colpotomizer is a cup-shaped surgical component used with the CerviGrip uterine manipulator during laparoscopic procedures. It helps the surgeon identify the vaginal fornices when making colpotomy incisions. A securing screw on the manipulator holds the colpotomizer in position.
Its double-ended design provides a 30 mm diameter at one end and a 40 mm diameter at the other. Each end has a partial circumferential raised lip, with a second lip 20 mm inward. These fixed distances help the surgeon gauge pelvic distances during dissection.
Listed Item
ColpoWave Colpotomizer blister pack containing 1 sterile unit
Material and Supply
The non-fenestrated colpotomizer is made from green ABS polymer. It is supplied sterile for single use and is made without natural rubber latex.
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 | Surgitools Pty, Ltd., Australia |
|---|---|
| FDA product code | HEW |
| Device type | Culdoscope (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1640 |
| 510(k) | K161065 |
| Record published | 2017-12-08 |
| Record revised | 2018-07-06 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CWD | In distribution | |
| CWD | 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 |
|---|---|
| K161065 | 2016-10-27 |
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.