510(k) Report

FDA applicant

Gps

Port Washington, NY2 decisions1997–19970 recalls

FDA records 2 decisions for Gps (Port Washington, NY) in 1997: 2 510(k) clearances. Most are in product codes HFW (Clamp, Umbilical) and HIB (Speculum, Vaginal, Nonmetal). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Gps’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gps since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gps by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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