GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS— 510(k) K930496

Substantially Equivalent

Birtcher Medical Systems, Inc.

FDA 510(k) clearance K930496 for GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS, Substantially Equivalent on 1993-04-20. Applicant: Birtcher Medical Systems, Inc..

Clearance details

Applicant: Birtcher Medical Systems, Inc.
Product code: Code GCI
Advisory panel: Gastroenterology, Urology
Date received: 1993-02-01
Decision date: 1993-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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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.