Identity
- Trade Name
- Coblation FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
- Device Name
- INTEGRATED CABLE WAND ICW, MENIVAC 45 FDA UDI
- Model / Reference
- ASC5500-01 FDA UDI
- Description
- INTEGRATED CABLE WAND ICW, MENIVAC 45 FDA UDI
Identifiers
- Catalog Number
- ASC5500-01 FDA UDI
- Primary DI / UDI-DI
- 00817470002126 FDA UDI
- 510(k) Number
- K033584 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
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Also classified as Endoscopic electrosurgical handpiece/electrode, bipolar, single-use.
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Cleared under the same submission
K033584 also covers:
- Coblation — Smith & Nephew, Inc.
- Coblation — Smith & Nephew, Inc.
- Coblation — Smith & Nephew, Inc.
- Coblation — Smith & Nephew, Inc.
- Coblation — Smith & Nephew, Inc.
- Coblation — Smith & Nephew, Inc.
- Coblation — Smith & Nephew, Inc.
- Coblation — Smith & Nephew, Inc.
- Coblation — Smith & Nephew, Inc.
- Coblation — Smith & Nephew, Inc.
- Coblation — Smith & Nephew, Inc.
- Coblation — Smith & Nephew, 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 |
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Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI bb682bb3-6dac-4295-a539-4b3aa139a0f9 36 fields · synced Jun 8, 2026