BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM— 510(k) K933319

Substantially Equivalent

Birtcher Medical Systems, Inc.

FDA 510(k) clearance K933319 for BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM, Substantially Equivalent on 1993-10-27. Applicant: Birtcher Medical Systems, Inc..

Clearance details

Applicant: Birtcher Medical Systems, Inc.
Product code: Code GCY
Advisory panel: General, Plastic Surgery
Date received: 1993-07-07
Decision date: 1993-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Braintree, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GCY

product code GCY

Malfunction: 786
Other: 1
Total: 787

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.