Clearance Summary
PENTAX Medical Auto Leakage Tester SHA-P6 received FDA 510(k) clearance under submission number K212201, sponsored by Pentax of America, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2021-10-01.
- Submission: K212201
- Applicant / Sponsor: Pentax of America, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2021-10-01
Classification & Regulation
This clearance is catalogued under FDA product code PCV and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.