# K131925: HS Nota

- Pathway: 510(k) (Traditional)
- Applicant: H.S. Hospital Services S.P.A.
- Decided: Oct 10, 2014 after 471 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002944 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002944: Precisa Biopsy Needle, H.S. Hospital Service S.R.L. (2000) Summary page 4.

## Indications for use
HS NOTA is an automatic biopsy needle and can be used in Fluoroscopic, CT and Mammographic procedures to obtain biopsies of soft tissue including those from prostate, kidney, breast and liver. The device is for prescription use, to be used by physicians in hospitals and clinics.

Source page: https://510kreport.com/device/K131925
Methodology: https://510kreport.com/methodology