510(k) K232080
K232080 is an FDA 510(k) premarket notification submitted by Innovacyn, Inc. for the device "Puracyn® Plus Antimicrobial Irrigation Solution". The FDA issued a decision of Substantially Equivalent on May 31, 2024. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Innovacyn, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2024
- Date Received
- July 13, 2023
- 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