Identity
- Trade Name
- Wallach® Endocell® EUDAMEDWallach Endocell FDA UDI
- Generic Name
- Endometrial biopsy kit FDA UDI
- Device Name
- Pipelle® Endometrial Suction Curette EUDAMEDEndometrial Cell Sampler FDA UDI
- Model / Reference
- 908016 EUDAMEDFDA UDI8200 EUDAMED
- Description
- Endometrial Cell Sampler FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937011265 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888937TD062ZR EUDAMED
- 510(k) Number
- K902693 FDA UDI
- FDA Product Code
- HFF FDA UDI
- EMDN Code
- U089010 UTERINE CURETTES, SINGLE-USE EUDAMED
- GMDN Term
- Endometrial biopsy kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1060 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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: Endometrial biopsy kit
Wallach Endocell by CooperSurgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
K902693 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI cb97e9f9-5dbd-4264-8677-3245e08668f0 34 fields · synced Jun 19, 2026
- EUDAMED ac29f3a2-7e25-45ef-83bf-e7c223f8ccc9 61 fields · synced Jun 19, 2026