1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)— 510(k) K230216
Substantially EquivalentStryker
FDA 510(k) clearance K230216 for 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), Substantially Equivalent on 2023-02-23. Applicant: Stryker.
Clearance details
- Applicant
- Stryker
- Product code
- Code GCJ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Jose, CA, US
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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.