Identity
- Trade Name
- SECURCUT FDA UDI
- Generic Name
- Soft-tissue biopsy needle, single-use FDA UDI
- Device Name
- SECURCUT 21GX40MM FDA UDI
- Model / Reference
- SECURCUT FDA UDI
- Description
- SECURCUT 21GX40MM FDA UDI
Identifiers
- Catalog Number
- S2104 FDA UDI
- Primary DI / UDI-DI
- 08033003347065 FDA UDI
- 510(k) Number
- K013071 FDA UDI
- FDA Product Code
- FCG FDA UDI
- GMDN Term
- Soft-tissue biopsy needle, single-use 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
Yes
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 — 40 Millimeter FDA UDINeedle Gauge — 21 Gauge FDA UDI
Category: Soft-tissue biopsy needle, single-use
Securcut by H.s. Hospital Service Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Soft-tissue biopsy needle, single-use.
- Disposable needle for reusable biopsy gun — Möller Medical GmbH · Class II
- Chiba needle — Möller Medical GmbH · Class II
- Inrad — Inrad · Class II
- CUSTOMED — Customed, Inc. · Class II
- Disposable needle for reusable biopsy gun — Möller Medical GmbH · Class II
- Manual TruCut Biopsy Cannula — Möller Medical GmbH · Class II
- Disposable needle for reusable biopsy gun — Möller Medical GmbH · Class II
- Disposable needle for reusable biopsy gun — Möller Medical GmbH · Class II
Cleared under the same submission
K013071 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
- H.s. Hospital Service Spa
Sources (1)
- FDA UDI a2e0eba1-25e9-4894-a7cf-59d4c4fbac63 37 fields · synced May 30, 2026