510(k) Report

FDA applicant

Chirurgische Instrumente

Balgheim, DE4 decisions1995–19950 recalls

FDA records 4 decisions for Chirurgische Instrumente (Balgheim, DE) in 1995: 4 510(k) clearances. Most are in product codes HET (Laparoscope, Gynecologic (And Accessories)) and HFB (Forceps, Biopsy, Gynecological). 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 Chirurgische Instrumente’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Chirurgische Instrumente since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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