Identity
- Trade Name
- BioPince™ Ultra Full Core Biopsy Instrument FDA UDI
- Generic Name
- End-cut biopsy gun handpiece/needle FDA UDI
- Device Name
- BioPince™ Ultra Full Core Biopsy Instrument with Co-Axial Introducer Needle (Biopsy Instrument: 16ga x 15cm)(Introducer Needle: 14ga x 11.8cm) FDA UDI
- Model / Reference
- 370-1580-03 FDA UDI
- Description
- BioPince™ Ultra Full Core Biopsy Instrument with Co-Axial Introducer Needle (Biopsy Instrument: 16ga x 15cm)(Introducer Needle: 14ga x 11.8cm) FDA UDI
Identifiers
- Catalog Number
- 370-1580-03 FDA UDI
- Primary DI / UDI-DI
- 00886333224098 FDA UDI
- 510(k) Number
- K904987 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- End-cut 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
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
Yes
FDA UDI
Category: End-cut biopsy gun handpiece/needle
BioPince™ Ultra Full Core Biopsy Instrument by Argon Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as End-cut biopsy gun handpiece/needle.
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- SemiCut — M.D.L. S.R.L. · Class II
- Themy — M.D.L. S.R.L. · Class II
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- Medline — MEDLINE INDUSTRIES, INC. · Class I
Cleared under the same submission
K904987 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 |
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Manufacturer
- Manufacturer
- Argon Medical Devices, Inc.
Sources (1)
- FDA UDI 5efd8225-a196-43e4-8c26-622324ef43a2 37 fields · synced Jun 9, 2026