Identity
- Trade Name
- FAST-GUN LIGHT FDA UDI
- Generic Name
- Side-notch biopsy gun handpiece/needle FDA UDI
- Device Name
- Reusable automatic biopsy gun for FAST-CUT needle FDA UDI
- Model / Reference
- FAST-GUN LIGHT FDA UDI
- Description
- Reusable automatic biopsy gun for FAST-CUT needle FDA UDI
Identifiers
- Catalog Number
- FSG03 FDA UDI
- Primary DI / UDI-DI
- 08033959228142 FDA UDI
- 510(k) Number
- K051506 FDA UDI
- FDA Product Code
- KNW FDA UDIFCG FDA UDI
- GMDN Term
- Side-notch biopsy gun handpiece/needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Side-notch biopsy gun handpiece/needle
Fast-Gun Light by Sterylab Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Side-notch biopsy gun handpiece/needle.
- M-Biopsy — Mermaid Medical A/S · Class II
- Disposable Automatic Biopsy Gun — Möller Medical GmbH · Class II
- Disposable Semi-Automatic Biopsy Gun — Möller Medical GmbH · Class II
- M-Biopsy — Mermaid Medical A/S · Class II
- MONOPTY — Bard Peripheral Vascular · Class II
- M-Biopsy — Mermaid Medical A/S · Class II
- TOP CUT — H.S. HOSPITAL SERVICE SPA · Class II
- M-Biopsy — Mermaid Medical A/S · Class II
Cleared under the same submission
K051506 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
- Sterylab Srl
Sources (1)
- FDA UDI a686c5af-1d85-409c-8c6b-bc8d1d6b3508 35 fields · synced May 30, 2026