OPSIS THORACOSCOPY VIDEO SYSTEM THORACICCAM AND THORACICCAM 360— 510(k) K941950
Substantially EquivalentBaxter 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. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- 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, through . 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.