Identity
- Trade Name
- COBLATION FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
- Device Name
- WEREWOLF FLOW 50 COBLATION WAND FDA UDI
- Model / Reference
- 72290037 FDA UDI
- Description
- WEREWOLF FLOW 50 COBLATION WAND FDA UDI
Identifiers
- Catalog Number
- 72290037 FDA UDI
- Primary DI / UDI-DI
- 00885556617472 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Coblation by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical handpiece/electrode, bipolar, single-use.
- AESCULAP — AESCULAP, INC. · Class II
- BE-ST Bipolar Forceps Straight — LACEY MANUFACTURING COMPANY LLC · Class II
- Valleylab — Covidien LP · Class II
- Burs — JIANGSU BONSS MEDICAL TECHNOLOGY CO., LTD. · Class IIa
- PLASMASORD — Gyrus Acmi, Inc. · Class II
- CoolSeal™ Trinity — Justright Surgical · Class II
- Bi-Tip™ Flextrode™ — ELLIQUENCE LLC · Class II
- Trigger-Flex® Quad Bipolar System — ELLIQUENCE LLC · Class II
Cleared under the same submission
K143235 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI a5b099a4-4061-4439-9ec7-f40fa7aef27f 36 fields · synced Jun 8, 2026