Clearance Summary
CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER received FDA 510(k) clearance under submission number K894778, 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 1989-12-06.
- Submission: K894778
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4150
- Decision date: 1989-12-06
Classification & Regulation
This clearance is catalogued under FDA product code HBO and 21 CFR 882.4150, within the Neurology review panel as a Class II device.