1788 4K Camera System with Advanced Imaging Modality— 510(k) K230605
Substantially EquivalentStryker
FDA 510(k) clearance K230605 for 1788 4K Camera System with Advanced Imaging Modality, Substantially Equivalent on 2023-03-31. Applicant: Stryker. Device class: 2.
Clearance details
- Applicant
- Stryker
- Product code
- Code GCJ
- 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
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More clearances from Stryker
view all- K231854 — 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM
- K230416 — Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®
- K230754 — L12 LED Light Source with AIM
- 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 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.