Clearance Summary
CODMAN SURGICAL PATTIE received FDA 510(k) clearance under submission number K880402, sponsored by Codman & Shurtleff, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1988-03-02.
- Submission: K880402
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4700
- Decision date: 1988-03-02
Classification & Regulation
This clearance is catalogued under FDA product code HBA and 21 CFR 882.4700, within the Neurology review panel as a Class II device.