510(k) K190155
K190155 is an FDA 510(k) premarket notification submitted by Viscus Biologics, LLC for the device "FibermarX Radiopaque Tissue Marker". The FDA issued a decision of Substantially Equivalent on Feb 27, 2019. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Viscus Biologics, LLC has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 27, 2019
- Date Received
- Jan 30, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type
- 510(k)