1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM— 510(k) K231854
Substantially EquivalentStryker
FDA 510(k) clearance K231854 for 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM, Substantially Equivalent on 2023-09-20. 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
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code OWN
view allMore clearances from Stryker
view all- K230416 — Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®
- K230754 — L12 LED Light Source with AIM
- K230605 — 1788 4K Camera System with Advanced Imaging Modality
- K230216 — 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)
- K222130 — 1688 4K Camera System with Advanced Imaging Modality
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.