Clearance Summary
PELVX GELLHORN VAGINAL PESSARY 603-608 received FDA 510(k) clearance under submission number K002329, sponsored by Deschutes Medical Products, Inc.. 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 2000-09-18.
- Submission: K002329
- Applicant / Sponsor: Deschutes Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.3575
- Decision date: 2000-09-18
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.