Clearance Summary
DISPOSABLE PERFORATOR received FDA 510(k) clearance under submission number K933894, 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 1993-12-10.
- Submission: K933894
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4305
- Decision date: 1993-12-10
Classification & Regulation
This clearance is catalogued under FDA product code HBF and 21 CFR 882.4305, within the Neurology review panel as a Class II device.