← Back to catalogue

Olympus

FDA UDI

Class II (US FDA UDI)

by Olympus Winter & Ibe GmbH

Identity

Trade Name
Olympus FDA UDI
Generic Name
Endometrial biopsy curette FDA UDI
Device Name
Curette, 24-28 Fr., 12° and 30° FDA UDI
Model / Reference
A22261A FDA UDI
Description
Curette, 24-28 Fr., 12° and 30° FDA UDI

Identifiers

Catalog Number
A22261A FDA UDI
Primary DI / UDI-DI
04042761021661 FDA UDI
510(k) Number
K904939 FDA UDI
FDA Product Code
EZO FDA UDI
GMDN Term
Endometrial biopsy curette FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4770 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Endometrial biopsy curette

Olympus by Olympus Winter & Ibe GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endometrial biopsy curette.

Cleared under the same submission

K904939 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Olympus Winter & Ibe GmbH

Sources (1)

  • FDA UDI 82fd5700-f2b8-46eb-b9e0-be61e35bec33 36 fields · synced May 30, 2026