Identity
- Trade Name
- ColpoWave Colpotomizer FDA UDI
- Generic Name
- Colpotomy tube FDA UDI
- Device Name
- ColpoWave Colpotomizer box containing 6 sterile units FDA UDI
- Model / Reference
- CWD FDA UDI
- Description
- ColpoWave Colpotomizer box containing 6 sterile units FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09351599000324 FDA UDI
- 510(k) Number
- K161065 FDA UDI
- FDA Product Code
- HEW FDA UDI
- GMDN Term
- Colpotomy tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Colpotomy tube
ColpoWave Colpotomizer by Surgitools Pty , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Colpotomy tube.
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- ColpotomizOR Tube System — SURGI SUPPLIES INTERNATIONAL PTY. LTD. · Class II
- ColpotomizOR Tube — SURGI SUPPLIES INTERNATIONAL PTY. LTD. · Class II
- ColpotomizOR Tube — SURGI SUPPLIES INTERNATIONAL PTY. LTD. · Class II
- ColpotomizOR Tube — THE O R COMPANY PTY LTD · Class II
- ColpoWave Balloon — Surgitools Pty , Ltd. · Class II
- ColpoWave Balloon — Surgitools Pty , Ltd. · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Surgitools Pty , Ltd.
Sources (1)
- FDA UDI d9687ab5-4a00-4f82-b9b9-afbac6691563 34 fields · synced Jun 1, 2026