Clearance Summary
P.A. MEDICAL VAGINAL IRRIGATION SET #1130 received FDA 510(k) clearance under submission number K854595, sponsored by Pa Medical Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1986-01-13.
- Submission: K854595
- Applicant / Sponsor: Pa Medical Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.5900
- Decision date: 1986-01-13
Classification & Regulation
This clearance is catalogued under FDA product code HED and 21 CFR 884.5900, within the Obstetrics/Gynecology review panel as a Class I device.