Combo-Pak

FDA UDI

Class II (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name: Combo-Pak FDA UDI
Generic Name: Endometrial biopsy kit FDA UDI
Device Name: Convenience Kit; Contents: 25 Endometrial Cell Samplers and 6 Os Finders FDA UDI
Model / Reference: 908010CP FDA UDI
Description: Convenience Kit; Contents: 25 Endometrial Cell Samplers and 6 Os Finders FDA UDI

Identifiers

Primary DI / UDI-DI: 60888937011144 FDA UDI
510(k) Number: K001545 FDA UDI
FDA Product Code: HHK FDA UDI
GMDN Term: Endometrial biopsy kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1175 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

Yes

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: Endometrial biopsy kit

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

Similar devices

Also classified as Endometrial biopsy kit.

Gynosampler — Gynetics Medical Products NV · Class II
Gynex — GYNEX CORPORATION · Class II
Patel Pipelle — TITUS MEDICAL LLC · Class II
Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd. · Class II
Bioteque Taiwan Ltd. — Bioteque Taiwan Ltd. · Class II
Echosampler — Gynetics Medical Products NV · Class II
Integra® Miltex® — Integra LifeSciences Production Corporation · Class II
Suresample, Endometrial Sampler — GYNEX CORPORATION · Class II

Cleared under the same submission

K001545 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: CooperSurgical, Inc.

Sources (1)

FDA UDI ec389bfa-3dc2-414b-91c2-cd644ef0c3a8 34 fields · synced Jun 9, 2026