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BioPince™ Ultra Full Core Biopsy Instrument

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 370-1080-03

by Argon Medical Devices, Inc.

Identity

Trade Name
BioPince EUDAMED
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 EUDAMED
BioPince™ Ultra Full Core Biopsy Instrument with Co-Axial Introducer Needle (Biopsy Instrument: 16ga x 10cm)(Introducer Needle: 14ga x 6.8cm) FDA UDI
Model / Reference
370-1080-03 EUDAMEDFDA UDI
Description
BioPince™ Ultra Full Core Biopsy Instrument with Co-Axial Introducer Needle (Biopsy Instrument: 16ga x 10cm)(Introducer Needle: 14ga x 6.8cm) FDA UDI

Identifiers

Catalog Number
370-1080-03 FDA UDI
Primary DI / UDI-DI
20886333224078 EUDAMED
00886333224074 FDA UDI
Basic UDI-DI
B-20886333224078 EUDAMED
510(k) Number
K904987 FDA UDI
FDA Product Code
KNW FDA UDI
EMDN Code
A01020199 NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER EUDAMED
GMDN Term
End-cut biopsy gun handpiece/needle FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
876.1075 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

BioPince™ Ultra Full Core Biopsy Instrument by Argon Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Cleared under the same submission

K904987 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Argon Medical Devices, Inc.

Sources (2)

  • FDA UDI d3a53258-b2c2-42d0-8c95-e9bc6235649e 37 fields · synced Oct 6, 2026
  • EUDAMED e04a6bb2-e028-4078-be42-1d379d9f8632 61 fields · synced Jul 12, 2026