VISUM BLADE LED SURGICAL LIGHTING SYSTEM— 510(k) K132747

Substantially Equivalent

Stryker Communications

FDA 510(k) clearance K132747 for VISUM BLADE LED SURGICAL LIGHTING SYSTEM, Substantially Equivalent on 2013-12-30. Applicant: Stryker Communications.

Clearance details

Applicant: Stryker Communications
Product code: Code FSY
Advisory panel: General, Plastic Surgery
Date received: 2013-09-03
Decision date: 2013-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flower Mound, TX, 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.