SHEATH, ENDOSCOPE— 510(k) K862059

Substantially Equivalent

Endovations

FDA 510(k) clearance K862059 for SHEATH, ENDOSCOPE, Substantially Equivalent on 1986-11-04. Applicant: Endovations.

Clearance details

Applicant: Endovations
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 1986-05-30
Decision date: 1986-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camp Hill, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FGE

product code FGE

Death: 52
Injury: 2,347
Malfunction: 9,798
Other: 1
Total: 12,198

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.