STELLAR SERIES SURGICAL LIGHTS WITH HERMES— 510(k) K021585
Substantially EquivalentSkytron, Div. the Kmw Group, Inc.
FDA 510(k) clearance K021585 for STELLAR SERIES SURGICAL LIGHTS WITH HERMES, Substantially Equivalent on 2002-11-13. Applicant: Skytron, Div. the Kmw Group, Inc..
Clearance details
- Applicant
- Skytron, Div. the Kmw Group, Inc.
- Product code
- Code FSY
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Grand Rapids, MI, US
Adverse events under product code FSY
product code FSY- Malfunction
- 2,759
- Other
- 1
- Total
- 2,760
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.