510(k) K223259
K223259 is an FDA 510(k) premarket notification submitted by Kane Biotech, Inc. for the device "coactiv+ Antimicrobial Wound Gel". The FDA issued a decision of Substantially Equivalent on May 24, 2023. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Kane Biotech, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 2023
- Date Received
- October 24, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type