Clearance Summary
SUNDT AVM MICRO CLIP received FDA 510(k) clearance under submission number K902544, 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 1990-09-20.
- Submission: K902544
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4175
- Decision date: 1990-09-20
Classification & Regulation
This clearance is catalogued under FDA product code HCI and 21 CFR 882.4175, within the Neurology review panel as a Class II device.