Identity
- Trade Name
- Semi-automatic Biopsy Needle - BIM16/10i 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
- BIM16/10i 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
- 04262410680821 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
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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 100 Millimeter FDA UDINeedle Gauge — 16 Gauge FDA UDI
Category: End-cut biopsy gun handpiece/needle
Semi-automatic Biopsy Needle - BIM16/10i by ITP Innovative Tomography Products GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as End-cut biopsy gun handpiece/needle.
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- 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
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI e4f341a7-8cba-46ca-935c-19527928b4b3 37 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced May 22, 2026