Zumi

FDA UDI

Class II (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name: ZUMI FDA UDI
Generic Name: Uterine manipulator, single-use FDA UDI
Device Name: ZUMI 4.5™ Uterine Manipulator-Injector O.D.: 4.5 mm • Length: 33 cm (13") FDA UDI
Model / Reference: ZSI1151 FDA UDI
Description: ZUMI 4.5™ Uterine Manipulator-Injector O.D.: 4.5 mm • Length: 33 cm (13") FDA UDI

Identifiers

Primary DI / UDI-DI: 00888937013221 FDA UDI
510(k) Number: K941458 FDA UDI
FDA Product Code: LKF FDA UDI
GMDN Term: Uterine manipulator, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.4530 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: Uterine manipulator, single-use

Zumi by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Uterine manipulator, single-use.

Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd. · Class II
ColpotomizOR Tube System — SURGI SUPPLIES INTERNATIONAL PTY. LTD. · Class II
CerviGrip Uterine Manipulator — Surgitools Pty , Ltd. · Class II
ColpotomizOR Tube System — SURGI SUPPLIES INTERNATIONAL PTY. LTD. · Class II
blueendo — TROKAMED GmbH · Class II
Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd. · Class II
McCarus-Volker FORNISEE® SYSTEM — LSI Solutions, Inc. · Class II
McCarus-Volker FORNISEE® SYSTEM — LSI Solutions, Inc. · Class II

Cleared under the same submission

K941458 also covers:

ZUI — CooperSurgical, Inc.

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: CooperSurgical, Inc.

Sources (1)

FDA UDI b4d9994c-43a4-45a3-a6b4-6a8e00f55ecc 34 fields · synced Jun 9, 2026