510(k) K162759
K162759 is an FDA 510(k) premarket notification submitted by Keranetics, LLC for the device "KeraStat(R) Gel". The FDA issued a decision of Substantially Equivalent on Jun 2, 2017. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Keranetics, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 2, 2017
- Date Received
- Sep 30, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Dressing With Animal-Derived Material(S)
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)