Clearance Summary
RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack) received FDA 510(k) clearance under submission number K163667, sponsored by Health Beacons, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2017-04-28.
- Submission: K163667
- Applicant / Sponsor: Health Beacons, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4300
- Decision date: 2017-04-28
Classification & Regulation
This clearance is catalogued under FDA product code PBY and 21 CFR 878.4300, within the General, Plastic Surgery review panel as a Class II device.