Clearance Summary
OmniGuide RFID Surgical Laser Fibers received FDA 510(k) clearance under submission number K230819, sponsored by Omni-Guide Holdings, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2023-04-21.
- Submission: K230819
- Applicant / Sponsor: Omni-Guide Holdings, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2023-04-21
Classification & Regulation
This clearance is catalogued under FDA product code GEX and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.