Clearance Summary
CapsoCam Plus (SV-3) received FDA 510(k) clearance under submission number K183192, sponsored by CapsoVision, Inc.. 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 2019-04-19.
- Submission: K183192
- Applicant / Sponsor: CapsoVision, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1300
- Decision date: 2019-04-19
Classification & Regulation
This clearance is catalogued under FDA product code NEZ and 21 CFR 876.1300, within the Gastroenterology, Urology review panel as a Class II device.