Clearance Summary
AME PINSITE SHIELD(TM) received FDA 510(k) clearance under submission number K884798, sponsored by American Medical Electronics, 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 1989-02-10.
- Submission: K884798
- Applicant / Sponsor: American Medical Electronics, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 1989-02-10
Classification & Regulation
This clearance is catalogued under FDA product code JEC and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.