STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]— 510(k) K151243
Substantially EquivalentStryker Endoscopy
FDA 510(k) clearance K151243 for STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit], Substantially Equivalent on 2015-08-20. Applicant: Stryker Endoscopy. Device class: 2.
Clearance details
- Applicant
- Stryker Endoscopy
- Product code
- Code FCS
- Device class
- Class 2
- Regulation
- 21 CFR 876.4020
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.