510(k) K911461— SURGITRON

Substantially Equivalent

Ellman Intl. Mfg., Inc.

Clearance details

Applicant: Ellman Intl. Mfg., Inc.
Product code: Code GCI
Advisory panel: Gastroenterology, Urology
Date received: 1991-04-03
Decision date: 1991-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hewlett, NY, US

Adverse events under product code GCI

product code GCI

Malfunction: 635
Total: 635

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.