510(k) K172010
K172010 is an FDA 510(k) premarket notification submitted by Gel-E, Inc. (Formerly Remedium Technologies, Inc.) for the device "gel-e Bandage". The FDA issued a decision of Substantially Equivalent on Dec 7, 2017. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 7, 2017
- Date Received
- Jul 3, 2017
- 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)