Clearance Summary
BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1 received FDA 510(k) clearance under submission number K010510, sponsored by A & A Medical, 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 2001-05-16.
- Submission: K010510
- Applicant / Sponsor: A & A Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1720
- Decision date: 2001-05-16
Classification & Regulation
This clearance is catalogued under FDA product code HET and 21 CFR 884.1720, within the Obstetrics/Gynecology review panel as a Class II device.