510(k) K930302— BIRTCHER SURE CLEAN INSTRUMENT SYSTEM

Substantially Equivalent

Birtcher Medical Systems, Inc.

Clearance details

Applicant: Birtcher Medical Systems, Inc.
Product code: Code GCI
Advisory panel: Gastroenterology, Urology
Date received: 1993-01-21
Decision date: 1993-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Duluth, GA, 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.