510(k) Report

Devices descending from K133542

14 later devices reach Puracyn Plus Skin and Wound through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232080Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20241—
+1K181428Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc.20195—
+1K180305Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)Aquilabs Us, LLC20180—
+1K142592CleanSmart Wound CleanserSimple Science, LLC20154—
+2K251757Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.20260—
+2K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC20204—
+2K160095Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial…Simple Science, LLC20163—
+3K213616BD Surgiphor Antimicrobial Irrigation SystemBecton, Dickinson and Company20223—
+3K181074Simple Science Antimicrobial Facial and Eyelid CleanserSimple Science, LLC20182—
+4K233399Microdacyn Wound Care SolutionSonoma Pharmaceuticals, Inc.20241—
+4K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd20222—
+5K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.20260—
+5K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD)20260—
+5K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)Bd20260—