510(k) K163667
K163667 is an FDA 510(k) premarket notification submitted by Health Beacons, Inc. for the device "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)". The FDA issued a decision of Substantially Equivalent on April 28, 2017. The device falls under product code PBY (Temporary Tissue Marker), a Class II device regulated under 21 CFR 878.4300. Health Beacons, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2017
- Date Received
- December 27, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Temporary Tissue Marker
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type
To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue.