FDA applicant

Sopro

Marseille, FR25 decisions1997–20230 recalls

FDA records 25 decisions for Sopro (Marseille, FR) from 1997 to 2023: 25 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and EIA (Unit, Operative Dental). Its devices cite 14 predicates, 6 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 Sopro’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007high 3 (2007) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sopro’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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Other applicant names beginning “Sopro”

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

Sopro - Acteon Group 4 Sopro-Comeg GmbH 1

Sopro

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Sopro”