510(k) Report

FDA applicant

Health Value Creation B.V., Trading AS Corporis Medical

Maastricht, NL2 decisions2023–20260 recalls

FDA records 2 decisions for Health Value Creation B.V., Trading AS Corporis Medical (Maastricht, NL) from 2023 to 2026: 2 510(k) clearances. All are in product code OCW (Endoscopic Tissue Approximation Device). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Health Value Creation B.V. (trading as Corporis Medical)”.

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 Health Value Creation B.V., Trading AS Corporis Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 12026 (partial year): 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Health Value Creation B.V., Trading AS Corporis Medical by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Health Value Creation B.V., Trading AS…’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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