STRYKER LED LIGHTSOURCE— 510(k) K082813
Substantially EquivalentStryker Corp.
FDA 510(k) clearance K082813 for STRYKER LED LIGHTSOURCE, Substantially Equivalent on 2008-12-19. Applicant: Stryker Corp.. Device class: 2.
Clearance details
- Applicant
- Stryker Corp.
- 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
- San Jose, CA, US
Recent devices under product code FCW
view allMore clearances from Stryker Corp.
view allAdverse 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 →
Recalls naming K082813
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082813.
Data sourced from openFDA. This site is unofficial and independent of the FDA.