SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device,…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K160316 FDA 510(k)
- FDA Product Code
- KNW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1075 FDA 510(k)
- Regulation Number
- 876.1075 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SemiCut Semi-automatic Biopsy Needle is a semi-automatic spring-powered biopsy device designed for soft tissue sampling. It incorporates a coaxial introducer needle with a trocar stylet and chamfered tip, enabling precise tissue penetration and core sample acquisition from organs such as the liver, thyroid, kidney, breast, lung, and prostate. The device operates via a guillotine system to cut and retain tissue samples securely within the cannula.
This device is supplied as either a disposable (Themy Automatic) or reusable (Palium Automatic) system, with multiple needle sizes available for compatibility with the manufacturer’s semi-automatic biopsy guns. It is intended for use in clinical settings such as radiology, urology, and gastroenterology, adhering to FDA 510(k) clearance and MDD compliance. Sterility and single-use or reusable status depend on the specific model, with no MRI safety restrictions noted.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SemiCut - Mdl Srl, SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy ..., SemiCut Semi-automatic Biopsy Needle, Themy… - FDA.report
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K160316 | Class II | Active |
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Manufacturer
- Manufacturer
- M.d.l. S.r.l.
Sources (2)
- FDA 510(k) K160316 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026