Identity
- Trade Name
- QUANTUM 2 FDA UDI
- Generic Name
- Electrosurgical system generator FDA UDI
- Device Name
- RF12000 Q2 SERVICE CONTROLLER-ONLY PACKAGE FDA UDI
- Model / Reference
- 28168-59 FDA UDI
- Description
- RF12000 Q2 SERVICE CONTROLLER-ONLY PACKAGE FDA UDI
Identifiers
- Catalog Number
- 28168-59 FDA UDI
- Primary DI / UDI-DI
- 00817470001594 FDA UDI
- 510(k) Number
- K082666 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical system generator 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrosurgical system generator
Quantum 2 by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrosurgical system generator.
- Cook — COOK INCORPORATED · Class II
- LEEP PRECISION™ Generator — CooperSurgical, Inc. · Class II
- AEXTM — MEDTRONIC, INC. · Class II
- Cook — COOK INCORPORATED · Class II
- Endovapor® — JOIMAX, INC. · Class II
- PerFect TCS — Coltene/Whaledent Inc. · Class II
- Valleylab — Covidien LP · Class II
- VFS1 Generator Main Unit — FHC, INC. · Class II
Cleared under the same submission
K082666 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 83321520-a23a-4567-9e86-31b7016a5fb9 36 fields · synced Jun 8, 2026