Identity
- Trade Name
- VERSITIP FDA UDI
- Generic Name
- Endoscopic light source adaptor FDA UDI
- Device Name
- ACMI INSTRUMENT AI VERSITIP ADAPTOR FOR 4.0 MM AND 5.0 MM LIGHT GUIDES INTENDED TO INTERFACE SMITH and NEPHEW GEMINI UNIVERSAL FIBER OPTIC LIGHT CABLES WITH ACMI ENDOSCOPES FDA UDI
- Model / Reference
- 2141 FDA UDI
- Description
- ACMI INSTRUMENT AI VERSITIP ADAPTOR FOR 4.0 MM AND 5.0 MM LIGHT GUIDES INTENDED TO INTERFACE SMITH and NEPHEW GEMINI UNIVERSAL FIBER OPTIC LIGHT CABLES WITH ACMI ENDOSCOPES FDA UDI
Identifiers
- Catalog Number
- 2141 FDA UDI
- Primary DI / UDI-DI
- 03596010103291 FDA UDI
- 510(k) Number
- K914919 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Endoscopic light source adaptor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Endoscopic light source adaptor
Versitip by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K914919 also covers:
- GEMINI — Smith & Nephew, Inc.
- GEMINI — Smith & Nephew, Inc.
- GEMINI — Smith & Nephew, Inc.
- GEMINI — Smith & Nephew, Inc.
- GEMINI — Smith & Nephew, Inc.
- GEMINI — Smith & Nephew, Inc.
- LIGHT GUIDE — Smith & Nephew, Inc.
- LIGHT GUIDE — Smith & Nephew, Inc.
- STORZ — Smith & Nephew, Inc.
- VERSITIP — Smith & Nephew, Inc.
- VERSITIP — Smith & Nephew, Inc.
- VERSITIP — 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 bad05dc2-1b25-4ade-a896-187f171d26ba 36 fields · synced Jun 8, 2026