Clearance Summary
OAC (OPTICAL ASPIRATING CURETTE) received FDA 510(k) clearance under submission number K980096, sponsored by Imagyn Medical Technologies, 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 1998-05-01.
- Submission: K980096
- Applicant / Sponsor: Imagyn Medical Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4530
- Decision date: 1998-05-01
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.