GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT— 510(k) K974084

Substantially Equivalent

Getinge/Castle, Inc.

FDA 510(k) clearance K974084 for GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT, Substantially Equivalent on 1998-03-03. Applicant: Getinge/Castle, Inc..

Clearance details

Applicant: Getinge/Castle, Inc.
Product code: Code FSY
Advisory panel: General, Plastic Surgery
Date received: 1997-10-29
Decision date: 1998-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Charleston, SC, US

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Adverse events under product code FSY

product code FSY

Malfunction: 2,759
Other: 1
Total: 2,760

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.