510(k) Report

FDA applicant

Novatech SA

La Ciotat Cedex, FR5 decisions1997–20250 recalls

FDA records 5 decisions for Novatech SA (La Ciotat Cedex, FR) from 1997 to 2025: 5 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and NWA (Prosthesis, Tracheal, Preformed/Molded). Since 2016 its 510(k)s took a median of 184 days from receipt to decision, against 99 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 2 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 Novatech SA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2016: 12017: 12024: 12025: 1
2007high 1 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Novatech SA’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GCJLaparoscope, General & Plastic Surgery2decisions
  • NWAProsthesis, Tracheal, Preformed/Molded2decisions
  • EOQBronchoscope (Flexible Or Rigid)1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 184 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 99 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K971509EndoxaneNovatech SA · 19976cite it
  • K151832Novatech TalcairNovatech SA · 20161cites it

What has FDA decided for it lately?

  • K242324Dutau-Novatech®Novatech SA · 2025
  • K243126Tracheobronxane™ Dumon®Novatech SA · 2024
  • K170030Novatech TalcairNovatech SA · 2017
  • K151832Novatech TalcairNovatech SA · 2016
  • K971509EndoxaneNovatech SA · 1997

All 5 as Novatech SA →