Identity
- Trade Name
- Forsvall biopsy needle FDA UDI
- Generic Name
- End-cut biopsy gun needle FDA UDI
- Device Name
- The Forsvall biopsy needle system for prostate biopsy consists of two items: the Forsvall biopsy needle and the Forsvall biopsy gun. The Forsvall biopsy needle is intended for use with the Forsvall biopsy gun. The Forsvall biopsy gun is reusable and the biopsy needle is single use. The Forsvall biopsy system uses a spring loaded gun that mediates a biopsy needle with a side notch used to obtain tissue samples. The biopsy gun is made of metal and hard plastic and the 16/18 gauge 10/15/20/25 cm biopsy needle is made of stainless medical grade steel. FDA UDI
- Model / Reference
- Mech-00286 FDA UDI
- Description
- The Forsvall biopsy needle system for prostate biopsy consists of two items: the Forsvall biopsy needle and the Forsvall biopsy gun. The Forsvall biopsy needle is intended for use with the Forsvall biopsy gun. The Forsvall biopsy gun is reusable and the biopsy needle is single use. The Forsvall biopsy system uses a spring loaded gun that mediates a biopsy needle with a side notch used to obtain tissue samples. The biopsy gun is made of metal and hard plastic and the 16/18 gauge 10/15/20/25 cm biopsy needle is made of stainless medical grade steel. FDA UDI
Identifiers
- Catalog Number
- 24171-14-04 FDA UDI
- Primary DI / UDI-DI
- 07309861000048 FDA UDI
- FDA Product Code
- KNW 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: End-cut biopsy gun needle
Forsvall biopsy needle by Xaga Surgical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as End-cut biopsy gun needle.
- FAST-CUT B — STERYLAB SRL · Class II
- 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
- FAST-CUT B — STERYLAB SRL · Class II
- FAST-CUT B — STERYLAB SRL · Class II
- FAST-CUT — STERYLAB SRL · Class II
- Palium Needle — M.D.L. S.R.L. · Class I
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 |
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Manufacturer
- Manufacturer
- Xaga Surgical
Sources (1)
- FDA UDI e1b30d83-9a04-445d-8268-b55410049a9c 34 fields · synced Jun 8, 2026