510(k) K213652
K213652 is an FDA 510(k) premarket notification submitted by Cresilon, Inc. for the device "Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)". The FDA issued a decision of Substantially Equivalent on June 28, 2023. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device. Cresilon, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 2023
- Date Received
- November 19, 2021
- 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.