Clearance Summary
REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS received FDA 510(k) clearance under submission number K022748, sponsored by Medical Device Services. 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 2002-10-09.
- Submission: K022748
- Applicant / Sponsor: Medical Device Services
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1720
- Decision date: 2002-10-09
Classification & Regulation
This clearance is catalogued under FDA product code HET and 21 CFR 884.1720, within the Obstetrics/Gynecology review panel as a Class II device.