510(k) K260185
- Device
- 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality
- Applicant
- Stryker Endoscopy
- 510(k) number
- K260185
- Product code
- GCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-02-18
- Date received
- 2026-01-21
- Regulation
- 876.1500
- Classification name
- Laparoscope, General & Plastic Surgery
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Divya Sekar
- Address
- 5900 Optical Ct. San Jose CA US 95138 95138
FDA Registration Numbers
- 3002808148
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Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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