510(k) K182811
K182811 is an FDA 510(k) premarket notification submitted by Gel-E, Inc. for the device "gel-e Flex+". The FDA issued a decision of Substantially Equivalent on Aug 29, 2019. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device. Gel-E, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 29, 2019
- Date Received
- Oct 3, 2018
- 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.