Identity
- Trade Name
- ABLATOR FDA UDI
- Generic Name
- Endoscopic surgical probe FDA UDI
- Device Name
- ABLATOR VULCAN 60 DEG FDA UDI
- Model / Reference
- 7209657 FDA UDI
- Description
- ABLATOR VULCAN 60 DEG FDA UDI
Identifiers
- Catalog Number
- 7209657 FDA UDI
- Primary DI / UDI-DI
- 03596010470355 FDA UDI
- 510(k) Number
- K003893 FDA UDI
- FDA Product Code
- HRX FDA UDIGEI FDA UDI
- GMDN Term
- Endoscopic surgical probe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 FDA UDI878.4400 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 surgical probe
Ablator by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic surgical probe.
- Tecomet — Tecomet,Inc · Class I
- ENDOTRAC — Stryker Corp. · Class II
- MAGNETIC PROBE — SONTEC INSTRUMENTS, INC. · Class I
- Tecomet — Tecomet,Inc · Class I
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- MaxMoreSpine — Hoogland Spine Products, GmbH · Class I
- Lightning — RESPONSIVE ORTHOPEDICS LLC · Class I
- Rasp Probe — Biomet Orthopedics, Inc. · Class I
Cleared under the same submission
K003893 also covers:
- ABLAOR / EFLEX — Smith & Nephew, Inc.
- ABLATOR — Smith & Nephew, Inc.
- ABLATOR — Smith & Nephew, Inc.
- ABLATOR — Smith & Nephew, Inc.
- ABLATOR — Smith & Nephew, Inc.
- ABLATOR — Smith & Nephew, Inc.
- ABLATOR — Smith & Nephew, Inc.
- ABLATOR — Smith & Nephew, Inc.
- ABLATOR — Smith & Nephew, Inc.
- ABLATOR — Smith & Nephew, Inc.
- ABLATOR — Smith & Nephew, Inc.
- ABLATOR — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 7a2256fc-7a57-4fbf-8fcd-9d6d17890a52 36 fields · synced Jun 8, 2026