510(k) Report

FDA applicant

Nissha Medical Technologies Sas

Conflans Ste Honorine, FR2 decisions2021–20210 recalls

FDA records 2 decisions for Nissha Medical Technologies Sas (Conflans Ste Honorine, FR) in 2021: 2 510(k) clearances. Most are in product codes OCX (Endoscopic Irrigation/Suction System) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Nissha Medical Technologies, Ltd.”.

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 Nissha Medical Technologies Sas’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2021: 2
2021high 2 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Nissha Medical Technologies Sas by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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