510(k) K243415
K243415 is an FDA 510(k) premarket notification submitted by P.G.F. Industry Solutions GmbH for the device "Granudacyn® Wound Irrigation Solution". The FDA issued a decision of Substantially Equivalent on Jul 22, 2025. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 22, 2025
- Date Received
- Nov 1, 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