Clearance Summary
TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM received FDA 510(k) clearance under submission number K963505, sponsored by Tenet Medical Engineering. 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 1997-02-14.
- Submission: K963505
- Applicant / Sponsor: Tenet Medical Engineering
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4900
- Decision date: 1997-02-14
Classification & Regulation
This clearance is catalogued under FDA product code HHP and 21 CFR 884.4900, within the Obstetrics/Gynecology review panel as a Class II device.