Clearance Summary
AGEE-WRISTJACK PRE-DRILL KIT received FDA 510(k) clearance under submission number K942906, sponsored by Hand Biomechanics Lab, 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 1994-12-22.
- Submission: K942906
- Applicant / Sponsor: Hand Biomechanics Lab, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1994-12-22
Classification & Regulation
This clearance is catalogued under FDA product code HTW and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.