Clearance Summary
ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM received FDA 510(k) clearance under submission number K111843, sponsored by Smith & Nephew Inc., Endoscopy Div.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2011-11-14.
- Submission: K111843
- Applicant / Sponsor: Smith & Nephew Inc., Endoscopy Div.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2011-11-14
Classification & Regulation
This clearance is catalogued under FDA product code OLO and 21 CFR 882.4560, within the Neurology review panel as a Class II device.