Clearance Summary
5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack) received FDA 510(k) clearance under submission number K181692, 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 2018-09-25.
- Submission: K181692
- 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: 2018-09-25
Classification & Regulation
This clearance is catalogued under FDA product code NEU and 21 CFR 878.4300, within the General, Plastic Surgery review panel as a Class II device.