Clearance Summary
SUNDT SLIM-LINE ANEURYSM CLIP APPLIER received FDA 510(k) clearance under submission number K982379, sponsored by Johnson & Johnson Professionals, 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 1998-12-18.
- Submission: K982379
- Applicant / Sponsor: Johnson & Johnson Professionals, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4175
- Decision date: 1998-12-18
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.