510(k) Report

FDA applicant

H.S. Hospital Services S.P.A.

Boca Raton, FL4 decisions2001–20140 recalls

FDA records 4 decisions for H.S. Hospital Services S.P.A. (Boca Raton, FL) from 2001 to 2014: 4 510(k) clearances. All are in product code FCG (Biopsy Needle). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided H.S. Hospital Services S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — H.S. Hospital Services S.P.A. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FCGBiopsy Needle4decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K131925HS NotaH.S. Hospital Services S.P.A. · 2014
  • K013071Securcut Aspiration Biopsy NeedleH.S. Hospital Services S.P.A. · 2001
  • K013070Jamshidi Biopsy NeedleH.S. Hospital Services S.P.A. · 2001
  • K013069BiospeedH.S. Hospital Services S.P.A. · 2001

All 4 as H.S. Hospital Services S.P.A. →