L10 LED Light Source with AIM, L11 LED Light Source with AIM— 510(k) K191046
Substantially EquivalentStryker
FDA 510(k) clearance K191046 for L10 LED Light Source with AIM, L11 LED Light Source with AIM, Substantially Equivalent on 2019-05-10. Applicant: Stryker. Device class: 2.
Clearance details
- Applicant
- Stryker
- Product code
- Code OWN
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Jose, CA, US
Recent devices under product code OWN
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- K230216 — 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)
Adverse events under product code OWN
product code OWN- Malfunction
- 1,286
- Total
- 1,286
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.