Clearance Summary
GENERAL UTILITY SURG. SCISSORS #460180- received FDA 510(k) clearance under submission number K800721, sponsored by Edward Weck, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1980-05-08.
- Submission: K800721
- Applicant / Sponsor: Edward Weck, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1980-05-08
Classification & Regulation
This clearance is catalogued under FDA product code HRR and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.