Clearance Summary
SDC4K Information Management System with Device and Voice Control Package received FDA 510(k) clearance under submission number K220108, sponsored by Stryker Endoscopy. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2022-02-09.
- Submission: K220108
- Applicant / Sponsor: Stryker Endoscopy
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2022-02-09
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.