Clearance Summary
PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE received FDA 510(k) clearance under submission number K012277, sponsored by Sims Portex , Ltd.. 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 2002-02-11.
- Submission: K012277
- Applicant / Sponsor: Sims Portex , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.3575
- Decision date: 2002-02-11
Classification & Regulation
This clearance is catalogued under FDA product code HHW and 21 CFR 884.3575, within the Obstetrics/Gynecology review panel as a Class II device.