K241401
- 510(k) number
- K241401
- Device name
- Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
- Applicant
- Stryker Endoscopy CA · US
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2024-08-15
- Date received
- 2024-05-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K241401.pdf
Official FDA record: K241401
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.