510(k) K243457
K243457 is an FDA 510(k) premarket notification submitted by Seriously Clean, Ltd. for the device "Nixall Antimicrobial Solutions Skin & Wound Hydrogel". The FDA issued a decision of Substantially Equivalent on May 2, 2025. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Seriously Clean, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2025
- Date Received
- Nov 7, 2024
- 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