1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality— 510(k) K260185
Substantially EquivalentStryker Endoscopy
FDA 510(k) clearance K260185 for 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality, Substantially Equivalent on 2026-02-18. Applicant: Stryker Endoscopy. Device class: 2.
Summary
Stryker Endoscopy lists two camera systems, the 1688 4K Camera System and the 1788 4K Camera System, each "with Advanced Imaging Modality." They're filed under product code GCJ (Laparoscope, General & Plastic Surgery). The record doesn't say how the two differ.
Class II, 21 CFR 876.1500. The General, Plastic Surgery review panel handled it as a Special 510(k), though the record lists Gastroenterology, Urology as the classification panel.
Stryker Endoscopy filed from San Jose, California. The substantially equivalent decision came 28 calendar days after receipt (January 21 to February 18, 2026).
Clearance details
- Applicant
- Stryker Endoscopy
- Product code
- Product 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
Recent devices under product code GCJ
view allMore clearances from Stryker Endoscopy
view allAdverse 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.