K251757
- 510(k) number
- K251757
- Device name
- Puracyn® Plus Antimicrobial Irrigation Solution
- Applicant
- Innovacyn, Inc. CA · US
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2026-01-05
- Date received
- 2025-06-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251757.pdf
Official FDA record: K251757
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.