STRYKER VISUM SURGICAL LIGHTING SYSTEM— 510(k) K031068

Substantially Equivalent

Stryker Endoscopy

FDA 510(k) clearance K031068 for STRYKER VISUM SURGICAL LIGHTING SYSTEM, Substantially Equivalent on 2003-08-12. Applicant: Stryker Endoscopy.

Clearance details

Applicant: Stryker Endoscopy
Product code: Code FSY
Advisory panel: General, Plastic Surgery
Date received: 2003-04-04
Decision date: 2003-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, 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.