510(k) K153189
K153189 is an FDA 510(k) premarket notification submitted by Scion Medical Technologies, LLC for the device "Beacon Tissue Marker (SE)". The FDA issued a decision of Substantially Equivalent on Dec 17, 2015. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Scion Medical Technologies, LLC has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 17, 2015
- Date Received
- Nov 3, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Marker, Radiographic, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type
- 510(k)