510(k) Report

FDA applicant

France Chirurgae Instrumentation

Cincinnati, OH1 decision2013–20130 recalls

FDA records 1 decision for France Chirurgae Instrumentation (Cincinnati, OH) in 2013: 1 510(k) clearance. All are in product code OKS (Lacrimal Stents And Intubation Sets). Its devices cite 3 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

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

FDA decisions per year

1in 2013

2013: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — France Chirurgae Instrumentation by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “France”

FDA records each applicant name separately; these may or may not be the same firm.