510(k) Report

FDA applicant

Microvasive

Milford, MA18 decisions1983–198725 recalls

FDA records 18 decisions for Microvasive (Milford, MA) from 1983 to 1987: 18 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and KNS (Unit, Electrosurgical, Endoscopic (With Or…). 25 recalls are 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 Microvasive’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Microvasive since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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