Clearance Summary
CONVERSE-GILLIES NEEDLE HOLDER received FDA 510(k) clearance under submission number K772388, 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 1978-01-20.
- Submission: K772388
- Applicant / Sponsor: Edward Weck, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1978-01-20
Classification & Regulation
This clearance is catalogued under FDA product code HXK and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.