OPSIS THORACOSCOPY VIDEO SYSTEM THORACICCAM AND THORACICCAM 360— 510(k) K941950

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K941950 for OPSIS THORACOSCOPY VIDEO SYSTEM THORACICCAM AND THORACICCAM 360, Substantially Equivalent on 1994-08-11. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1994-04-21
Decision date: 1994-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deerfield, IL, US

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Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.