FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Puracyn® Plus Antimicrobial Irrigation Solution
K Number: K251757
·
Decision Jan 5, 2026
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
4
Review Days
210
Basic Information
- Device Name
- Puracyn® Plus Antimicrobial Irrigation Solution
- K Number
- K251757
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innovacyn, Inc.
- Date Received
- June 9, 2025
- Decision Date
- January 5, 2026
- Product Code
- FRO
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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Other Clearances by Innovacyn, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232080 | Puracyn® Plus Antimicrobial Irrigation Solution | May 31, 2024 | Substantially Equivalent |
| K150799 | Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula | Nov 19, 2015 | Substantially Equivalent |
| K133542 | PURACYN PLUS SKIN AND WOUND | Apr 28, 2014 | Substantially Equivalent |