510(k) K142363
K142363 is an FDA 510(k) premarket notification submitted by Beeken Biomedical for the device "NUSTAT, NUSTAT XR". The FDA issued a decision of Substantially Equivalent on January 9, 2015. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device. Beeken Biomedical has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 2015
- Date Received
- August 25, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemostatic Wound Dressing Without Thrombin Or Other Biologics
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type
To temporarily control bleeding and cover external wounds.