Identity
- Trade Name
- Spirotome Spine FDA UDI
- Generic Name
- Soft-tissue biopsy needle, single-use FDA UDI
- Device Name
- The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver. The Spirotome Biopsy Needle Set contains: • A two-part introducer needle that consists of a cutting cannula and a trocar stylet • A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula - Injection needle • A release element This presentation has an external diameter of 10G (4 mm) and length of 150 mm. FDA UDI
- Model / Reference
- SS10SP FDA UDI
- Description
- The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver. The Spirotome Biopsy Needle Set contains: • A two-part introducer needle that consists of a cutting cannula and a trocar stylet • A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula - Injection needle • A release element This presentation has an external diameter of 10G (4 mm) and length of 150 mm. FDA UDI
Identifiers
- Catalog Number
- SS10SP FDA UDI
- Primary DI / UDI-DI
- 05407005001264 FDA UDI
- 510(k) Number
- K080095 FDA UDI
- FDA Product Code
- KNW 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
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Soft-tissue biopsy needle, single-use
Spirotome Spine by Bioncise — 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
K080095 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
- Bioncise
Sources (1)
- FDA UDI 8d62e714-69a4-4f80-a51a-7d94a799721c 35 fields · synced May 30, 2026