Automatic Biopsy Needle - BAM 16/20

FDA UDI

Class II (US FDA UDI)

by ITP Innovative Tomography Products GmbH

Identity

Trade Name: Automatic Biopsy Needle - BAM 16/20 FDA UDI
Generic Name: End-cut biopsy gun handpiece/needle FDA UDI
Device Name: The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate). FDA UDI
Model / Reference: BAM 16/20 FDA UDI
Description: The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate). FDA UDI

Identifiers

Primary DI / UDI-DI: 04262410686069 FDA UDI
510(k) Number: K233294 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 200 Millimeter FDA UDI
Needle Gauge — 16 Gauge FDA UDI

Category: End-cut biopsy gun handpiece/needle

Automatic Biopsy Needle - BAM 16/20 by ITP Innovative Tomography Products GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as End-cut biopsy gun handpiece/needle.

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Themy — M.D.L. S.R.L. · Class II
Tru-Core™ II Biopsy Instrument — Argon Medical Devices, Inc. · Class II
SemiCut — M.D.L. S.R.L. · Class II
SuperCore™ Biopsy Instrument — Argon Medical Devices, Inc. · Class II
Tru-Core™ II Biopsy Instrument — Argon Medical Devices, Inc. · Class II
SemiCut Coax. — M.D.L. S.R.L. · Class II
SuperCore Advantage™ — Argon Medical Devices, Inc. · Class II

Cleared under the same submission

K233294 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: ITP Innovative Tomography Products GmbH

Sources (1)

FDA UDI 92bce458-9453-4774-9a95-c2d29664b60d 37 fields · synced May 31, 2026