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Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spir…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K190378

by Bioncise NV

Identifiers

510(k) Number
K190378 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 Spirotome Endo is a manual, single-use, large-core soft tissue biopsy instrument designed for obtaining tissue samples. It features a stainless steel helical receiving needle, a stainless steel cutting cannula, and a polypropylene releasing element to facilitate precise tissue acquisition in endoscopic procedures.

This device is intended for use in gastroenterology and urology settings and is supplied as a sterile, single-use instrument. Available in gauges 08, 10, and 14, including a variant with a 10 mm helix, it adheres to FDA 510(k) and MDR regulatory standards. Storage and handling must comply with manufacturer guidelines to maintain sterility and functionality.

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: Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 ..., Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 ..., Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bioncise NV

Sources (2)

  • FDA 510(k) K190378 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026