Clearance Summary
HOOK PUNCH FORCEPS FOR ARTHROSCOPY received FDA 510(k) clearance under submission number K880331, sponsored by Kibbutz Gilgal Medical C/O Toam U.S.A. Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1988-02-18.
- Submission: K880331
- Applicant / Sponsor: Kibbutz Gilgal Medical C/O Toam U.S.A. Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 1988-02-18
Classification & Regulation
This clearance is catalogued under FDA product code HRX and 21 CFR 888.1100, within the Orthopedic review panel as a Class II device.