STORZ S6000 LIGHT SOURCE— 510(k) K905376
Substantially EquivalentStorz Instrument Co.
FDA 510(k) clearance K905376 for STORZ S6000 LIGHT SOURCE, Substantially Equivalent on 1991-01-23. Applicant: Storz Instrument Co.. Device class: 2.
Clearance details
- Applicant
- Storz Instrument Co.
- Product code
- Code FCW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
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Adverse events under product code FCW
product code FCW- Malfunction
- 912
- Other
- 1
- Total
- 913
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.