Puracyn® Plus Antimicrobial Irrigation Solution

FDA 510(k) K251757 · Innovacyn, Inc.

Substantially Equivalent

510(k) numberK251757

Submission

Device name
Puracyn® Plus Antimicrobial Irrigation Solution
Applicant
Innovacyn, Inc.
Rialto, CA, US
Received
June 9, 2025
Decision date
January 5, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FRO – Dressing, Wound, Drug
Device class
Unclassified

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K251929SilverCeuticals® Antimicrobial Wound GelFRO · Traditional Silverceuticals, Inc.06/24/2026SE
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K254073StatSeal DiscFRO · Traditional Merit Medical Systems, Inc.05/13/2026SE
K254191IWD-Gel™FRO · Traditional InnovaCorium, Inc.04/07/2026SE
K252023MiraChlor Antimicrobial Wound SolutionFRO · Traditional Letus Corporation03/25/2026SE
K251999Promogran Prisma™ Collagen Matrix with ORC and SilverFRO · Traditional Solventum Germany GmbH03/13/2026SE

More from Solventum Germany GmbH

510(k)DeviceDecision
K232080Puracyn® Plus Antimicrobial Irrigation SolutionFRO · Traditional 05/31/2024SE
K150799Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus…FRO · Traditional 11/19/2015SE
K133542Puracyn Plus Skin and WoundFRO · Traditional 04/28/2014SE

Questions and answers

When was Puracyn® Plus Antimicrobial Irrigation Solution cleared by the FDA?

Puracyn® Plus Antimicrobial Irrigation Solution (K251757) received a 510(k) decision of Substantially Equivalent on January 5, 2026, 210 days after the submission was received.

What is the product code of K251757?

The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.