510(k) Report

FDA applicant

Ab Medica Sas

Mary-Su-Cher, FR3 decisions2014–20260 recalls

FDA records 3 decisions for Ab Medica Sas (Mary-Su-Cher, FR) from 2014 to 2026: 3 510(k) clearances. All are in product code GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 5 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 Ab Medica Sas’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2014: 12015: 12026 (partial year): 1
2014high 1 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Ab Medica Sas by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GCJLaparoscope, General & Plastic Surgery3decisions

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K252957Pneumo Dissector HookAb Medica Sas · 2026
  • K151822ab medica irrigation/suction gravity systemAb Medica Sas · 2015
  • K140101Abmedica Reusable Laparoscopic Hand Instruments and TrocarsAb Medica Sas · 2014

All 3 as Ab Medica Sas →