REUSABLE ENDOSCOPIC ACCESSORY HANDLE— 510(k) K961762

Substantially Equivalent

United States Endoscopy Group, Inc.

FDA 510(k) clearance K961762 for REUSABLE ENDOSCOPIC ACCESSORY HANDLE, Substantially Equivalent on 1996-07-22. Applicant: United States Endoscopy Group, Inc..

Clearance details

Applicant: United States Endoscopy Group, Inc.
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 1996-05-07
Decision date: 1996-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

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Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

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.