K163667 is an FDA 510(k) clearance for the 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). This device is classified as a Temporary Tissue Marker (Class II - Special Controls, product code PBY).
Submitted by Health Beacons, Inc. (Concord, US). The FDA issued a Cleared decision on April 28, 2017, 122 days after receiving the submission on December 27, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300. To Temporarily (< 30 Days) Mark A Tissue Site Intended For Surgical Removal. The Tissue Marker Is Surgically Removed With The Target Tissue..
| 510(k) Number | K163667 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2016 |
| Decision Date | April 28, 2017 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | PBY - Temporary Tissue Marker |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4300 |
| Definition | To Temporarily (< 30 Days) Mark A Tissue Site Intended For Surgical Removal. The Tissue Marker Is Surgically Removed With The Target Tissue. |