Identity
- Trade Name
- M-Biopsy FDA UDI
- Generic Name
- Side-notch biopsy gun handpiece/needle FDA UDI
- Device Name
- Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or surgical histological biopsy samples from soft tissue by cutting from lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and pancreas, for microscopic examination. When used for breast biopsy, the product is for diagnosis only. FDA UDI
- Model / Reference
- N30118030 FDA UDI
- Description
- Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or surgical histological biopsy samples from soft tissue by cutting from lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and pancreas, for microscopic examination. When used for breast biopsy, the product is for diagnosis only. FDA UDI
Identifiers
- Catalog Number
- N30118030 FDA UDI
- Primary DI / UDI-DI
- 15711055002551 FDA UDI
- 510(k) Number
- K161409 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Side-notch 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
Dimensions & Sizes
- Size
- Length — 30 Centimeter FDA UDINeedle Gauge — 18 Gauge FDA UDI
Category: Side-notch biopsy gun handpiece/needle
M-Biopsy by Mermaid Medical A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Side-notch biopsy gun handpiece/needle.
- Disposable Automatic Biopsy Gun — Möller Medical GmbH · Class II
- Disposable Semi-Automatic Biopsy Gun — Möller Medical GmbH · Class II
- MONOPTY — Bard Peripheral Vascular · Class II
- TOP CUT — H.S. HOSPITAL SERVICE SPA · Class II
- TOP CUT — H.S. HOSPITAL SERVICE SPA · Class II
- MAX-CORE — Bard Peripheral Vascular · Class II
- TOP CUT — H.S. HOSPITAL SERVICE SPA · Class II
- Inrad — Inrad · Class II
Cleared under the same submission
K161409 also covers:
- M-Biopsy — Mermaid Medical A/S
- M-Biopsy — Mermaid Medical A/S
- M-Biopsy — Mermaid Medical A/S
- M-Biopsy — Mermaid Medical A/S
- M-Biopsy — Mermaid Medical A/S
- M-Biopsy — Mermaid Medical A/S
- M-Biopsy — Mermaid Medical A/S
- M-Biopsy — Mermaid Medical A/S
- M-Biopsy — Mermaid Medical A/S
- M-Biopsy — Mermaid Medical A/S
- M-Biopsy — Mermaid Medical A/S
- M-Biopsy — Mermaid Medical A/S
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
- Mermaid Medical A/S
Sources (1)
- FDA UDI 8e0dede1-7fed-486e-a1b3-7e68f9edda19 38 fields · synced May 30, 2026