510(k) K172155
K172155 is an FDA 510(k) premarket notification submitted by Statguard, LLC for the device "StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing". The FDA issued a decision of Substantially Equivalent on Apr 12, 2018. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 12, 2018
- Date Received
- Jul 17, 2017
- 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
- Review Panel
- SU
- Submission Type
- 510(k)
To temporarily control bleeding and cover external wounds.