Clearance Summary
PELVX DONUT, PELVX CUBE received FDA 510(k) clearance under submission number K974117, 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 1998-04-27.
- Submission: K974117
- 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: 1998-04-27
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.