DEVMED LAP WASH REUSABLE ENDOSCOPIC LENS WASH SHEATH— 510(k) K933416

Substantially Equivalent

Devmed Corp.

FDA 510(k) clearance K933416 for DEVMED LAP WASH REUSABLE ENDOSCOPIC LENS WASH SHEATH, Substantially Equivalent on 1993-08-10. Applicant: Devmed Corp..

Clearance details

Applicant: Devmed Corp.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1993-07-12
Decision date: 1993-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Beach Gardens, FL, US

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Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.