Clearance Summary
ANSPACH ACCESS CRANIAL PERFORATOR received FDA 510(k) clearance under submission number K982991, sponsored by The Anspach Effort, 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 1998-10-21.
- Submission: K982991
- Applicant / Sponsor: The Anspach Effort, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4305
- Decision date: 1998-10-21
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.