Clearance Summary
OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT received FDA 510(k) clearance under submission number K935434, sponsored by United States Surgical, A Division of Tyco Healthc. 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 1994-05-27.
- Submission: K935434
- Applicant / Sponsor: United States Surgical, A Division of Tyco Healthc
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1994-05-27
Classification & Regulation
This clearance is catalogued under FDA product code LKF and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.