510(k) K211570
K211570 is an FDA 510(k) premarket notification submitted by Hangzhou Zeo-Innov Life Technology Co., Ltd. for the device "Zeolite Hemostatic Gauze". The FDA issued a decision of Substantially Equivalent on February 10, 2022. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device. Hangzhou Zeo-Innov Life Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 2022
- Date Received
- May 21, 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.