Clearance Summary
PHASE I CURETTE received FDA 510(k) clearance under submission number K935822, sponsored by Phase I 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 1994-04-28.
- Submission: K935822
- Applicant / Sponsor: Phase I Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4530
- Decision date: 1994-04-28
Classification & Regulation
This clearance is catalogued under FDA product code HCY and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class I device.