BIOSPEED

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K013069 ↗

FDA Product Code

FCG

Device Class

Class II

Regulation

21 CFR Part 876.1075

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Hs Nota

  Class II

  FDA 510(k) K131925 Active Cleared 10 Oct 2014

• Jamshidi Biopsy Needle

  Class II

  FDA 510(k) K013070 Active Cleared 12 Dec 2001

• Securcut Aspiration Biopsy Needle

  Class II

  FDA 510(k) K013071 Active Cleared 12 Dec 2001

• What is the BIOSPEED biopsy needle used for?

  The BIOSPEED is a biopsy needle device specifically designed for obtaining tissue samples during diagnostic procedures in gastroenterology and urology specialties. It helps clinicians collect tissue samples for laboratory analysis and diagnosis.

• How is the BIOSPEED biopsy needle supplied?

  The BIOSPEED is supplied as a Class 2 medical device with FDA 510(k) clearance (K013069) and is regulated under product code FCG. It is manufactured by H.S. Hospital Services S.P.A. and available in various sizes as indicated by the multiple registration numbers associated with the device.

• Is the BIOSPEED biopsy needle single-use or reusable?

  The device data does not specify whether the BIOSPEED biopsy needle is single-use or reusable. For information on sterility and reuse, please consult the manufacturer's instructions for use or contact H.S. Hospital Services S.P.A. directly.

• What are the regulatory approvals for the BIOSPEED biopsy needle?

  The BIOSPEED biopsy needle has FDA 510(k) clearance (K013069) as a Class 2 medical device under product code FCG. It was cleared through the traditional pathway and is indicated for use in gastroenterology and urology procedures.