Cleared Traditional

Puracyn? Plus Antimicrobial Irrigation Solution

K232080 · Innovacyn, Inc. · General & Plastic Surgery
May 2024
Decision
323d
Days
—
Risk

About This 510(k) Submission

K232080 is an FDA 510(k) clearance for the Puracyn? Plus Antimicrobial Irrigation Solution, a Dressing, Wound, Drug, submitted by Innovacyn, Inc. (Rialto, US). The FDA issued a Cleared decision on May 31, 2024, 323 days after receiving the submission on July 13, 2023. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K232080 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 2023
Decision Date May 31, 2024
Days to Decision 323 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FRO — Dressing, Wound, Drug
Device Class —

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