ColpoWave Colpotomizer

FDA UDI

Class II (US FDA UDI)

by Surgitools Pty , Ltd.

Identity

Trade Name: ColpoWave Colpotomizer FDA UDI
Generic Name: Colpotomy tube FDA UDI
Device Name: ColpoWave Colpotomizer blister pack containing 1 sterile unit FDA UDI
Model / Reference: CWD FDA UDI
Description: ColpoWave Colpotomizer blister pack containing 1 sterile unit FDA UDI

Identifiers

Primary DI / UDI-DI: 09351599000317 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

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.

ColpotomizOR Tube System — SURGI SUPPLIES INTERNATIONAL PTY. LTD. · Class II
ColpotomizOR Tube — THE O R COMPANY PTY LTD · Class II
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

K161065 also covers:

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 c6d7c7d1-7204-4fd0-abef-cf09ae8e4248 34 fields · synced Jun 8, 2026