Clearance Summary
SAFE-T-CLAMP received FDA 510(k) clearance under submission number K971277, sponsored by Talon Medical, 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 1997-05-20.
- Submission: K971277
- Applicant / Sponsor: Talon Medical, Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1997-05-20
Classification & Regulation
This clearance is catalogued under FDA product code KNA and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.