510(k) K253326
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 1, 2026
- Date Received
- September 30, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Absorbable Gel For Intraoperative Use In Spine Surgery
- Device Class
- Class II
- Regulation Number
- 888.3047
- Review Panel
- OR
- Submission Type
This device is an absorbable gel implant for intraoperative use in spinal procedures that is applied to nerve roots after hemostasis has been achieved and prior to closure. The device is intended as an adjunct to the surgical procedure to reduce pain and neurological symptoms.