Clearance Summary
GYN DISPOSABLES TENACULUM 356T received FDA 510(k) clearance under submission number K073182, sponsored by Gyn-Disposables, 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 2007-11-28.
- Submission: K073182
- Applicant / Sponsor: Gyn-Disposables, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2007-11-28
Classification & Regulation
This clearance is catalogued under FDA product code HDC and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.