1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes— 510(k) K210088
Substantially EquivalentStryker
FDA 510(k) clearance K210088 for 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes, Substantially Equivalent on 2021-04-13. 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
- Traditional
- 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
- K230605 — 1788 4K Camera System with Advanced Imaging Modality
- K230216 — 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)
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.