Identity
- Trade Name
- FAST-CUT B FDA UDI
- Generic Name
- End-cut biopsy gun needle FDA UDI
- Device Name
- Biopsy needle for automatic gun 20G; 15cm FDA UDI
- Model / Reference
- FAST-CUT B FDA UDI
- Description
- Biopsy needle for automatic gun 20G; 15cm FDA UDI
Identifiers
- Catalog Number
- FSC2015B FDA UDI
- Primary DI / UDI-DI
- 08033959224540 FDA UDI
- 510(k) Number
- K051506 FDA UDI
- FDA Product Code
- KNW FDA UDIFCG FDA UDI
- GMDN Term
- End-cut biopsy gun 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
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: End-cut biopsy gun needle
Fast-Cut B by Sterylab Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as End-cut biopsy gun needle.
- UltraCore™ Biopsy Needle — Argon Medical Devices, Inc. · Class I
- Palium Needle — M.D.L. S.R.L. · Class I
- UltraCore™ Biopsy Needle — Argon Medical Devices, Inc. · Class I
- Palium Needle — M.D.L. S.R.L. · Class I
- FastCutE — M.D.L. S.R.L. · Class I
- Palium Needle — M.D.L. S.R.L. · Class I
- Palium Needle — M.D.L. S.R.L. · Class I
- UltraCore™ Biopsy Needle — Argon Medical Devices, Inc. · Class I
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 e8297410-e80e-4f2a-a12f-2501279baec4 35 fields · synced Jun 1, 2026