Clearance Summary
Self-retaining Retractor received FDA 510(k) clearance under submission number K161004, sponsored by Fetzer Medical GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2016-09-09.
- Submission: K161004
- Applicant / Sponsor: Fetzer Medical GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4800
- Decision date: 2016-09-09
Classification & Regulation
This clearance is catalogued under FDA product code GZT and 21 CFR 882.4800, within the Neurology review panel as a Class II device.