Identity
- Trade Name
- TOP CUT FDA UDI
- Generic Name
- Side-notch biopsy gun handpiece/needle FDA UDI
- Device Name
- TOP CUT M 14GX160MM FDA UDI
- Model / Reference
- TOP CUT M FDA UDI
- Description
- TOP CUT M 14GX160MM FDA UDI
Identifiers
- Catalog Number
- TOP 1416M FDA UDI
- Primary DI / UDI-DI
- 08033003347386 FDA UDI
- 510(k) Number
- K021525 FDA UDI
- FDA Product Code
- FCG 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
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 160 Millimeter FDA UDINeedle Gauge — 14 Gauge FDA UDI
Category: Side-notch biopsy gun handpiece/needle
Top Cut by H.s. Hospital Service Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Side-notch biopsy gun handpiece/needle.
- M-Biopsy — Mermaid Medical A/S · Class II
- Disposable Automatic Biopsy Gun — Möller Medical GmbH · Class II
- Disposable Semi-Automatic Biopsy Gun — Möller Medical GmbH · Class II
- M-Biopsy — Mermaid Medical A/S · Class II
- MONOPTY — Bard Peripheral Vascular · Class II
- M-Biopsy — Mermaid Medical A/S · Class II
- M-Biopsy — Mermaid Medical A/S · Class II
- MAX-CORE — Bard Peripheral Vascular · Class II
Cleared under the same submission
K021525 also covers:
- TOP CUT — H.S. HOSPITAL SERVICE SPA
- TOP CUT — H.S. HOSPITAL SERVICE SPA
- TOP CUT — H.S. HOSPITAL SERVICE SPA
- TOP CUT — H.S. HOSPITAL SERVICE SPA
- TOP CUT — H.S. HOSPITAL SERVICE SPA
- TOP CUT — H.S. HOSPITAL SERVICE SPA
- TOP CUT — H.S. HOSPITAL SERVICE SPA
- TOP CUT — H.S. HOSPITAL SERVICE SPA
- TOP CUT — H.S. HOSPITAL SERVICE SPA
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- H.s. Hospital Service Spa
Sources (1)
- FDA UDI 1ad4ad76-48b0-4500-aed0-72593580514c 37 fields · synced May 30, 2026