Clearance Summary
SANO CLIP APPLIERS & REMOVERS received FDA 510(k) clearance under submission number K881912, sponsored by Downs Surgical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1988-06-06.
- Submission: K881912
- Applicant / Sponsor: Downs Surgical , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4175
- Decision date: 1988-06-06
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.