HS Nota

FDA 510(k) K131925 · H.S. Hospital Services S.P.A.

Substantially Equivalent

510(k) numberK131925

Submission

Device name
HS Nota
Applicant
H.S. Hospital Services S.P.A.
Boca Raton, FL, US
Received
June 26, 2013
Decision date
October 10, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FCG – Biopsy Needle
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1075
Specialty
Gastroenterology, Urology

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K212423EndoDrill® Model XFCG · Traditional Bibbinstruments AB03/29/2023SE
K212822Disposable Coaxial Biopsy NeedleFCG · Traditional Suzhou Leapmed Healthcare Corporation07/06/2022SE
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More from Cook Ireland, Ltd.

510(k)DeviceDecision
K013071Securcut Aspiration Biopsy NeedleFCG · Traditional 12/12/2001SE
K013070Jamshidi Biopsy NeedleFCG · Traditional 12/12/2001SE
K013069BiospeedFCG · Traditional 12/12/2001SE

Questions and answers

When was HS Nota cleared by the FDA?

HS Nota (K131925) received a 510(k) decision of Substantially Equivalent on October 10, 2014, 471 days after the submission was received.

What is the product code of K131925?

The FDA product code is FCG – Biopsy Needle, a Class II (moderate risk) device regulated under 21 CFR 876.1075.