Clearance Summary
SINGLE CHANNEL BALLOON CANNULA received FDA 510(k) clearance under submission number K974801, sponsored by Conkin Surgical Instruments , Ltd.. 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 1998-07-09.
- Submission: K974801
- Applicant / Sponsor: Conkin Surgical Instruments , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1998-07-09
Classification & Regulation
This clearance is catalogued under FDA product code HDP and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.