Clearance Summary
PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 received FDA 510(k) clearance under submission number K050112, sponsored by Prime Pacific Health Innovations Corporation. 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 2005-03-15.
- Submission: K050112
- Applicant / Sponsor: Prime Pacific Health Innovations Corporation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5220
- Decision date: 2005-03-15
Classification & Regulation
This clearance is catalogued under FDA product code KPL and 21 CFR 876.5220, within the Gastroenterology, Urology review panel as a Class II device.