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FDA 510(k)

Puracyn® Plus Antimicrobial Irrigation Solution

K-Number: K251757 · 2026-01-05

ApplicantInnovacyn, Inc.
Decision Date2026-01-05
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Puracyn® Plus Antimicrobial Irrigation Solution is a medical device manufactured by Innovacyn, Inc.. It received FDA 510(k) clearance on 2026-01-05 under approval number K251757. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Puracyn® Plus Antimicrobial Irrigation Solution?

Puracyn® Plus Antimicrobial Irrigation Solution is a medical device that received FDA 510(k) clearance on 2026-01-05. It is manufactured by Innovacyn, Inc.. The 510(k) number is K251757.

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

Puracyn® Plus Antimicrobial Irrigation Solution received FDA 510(k) clearance on 2026-01-05, under approval number K251757.

What company makes Puracyn® Plus Antimicrobial Irrigation Solution?

Puracyn® Plus Antimicrobial Irrigation Solution is manufactured by Innovacyn, Inc..

What is the FDA product code for Puracyn® Plus Antimicrobial Irrigation Solution?

The FDA product code for Puracyn® Plus Antimicrobial Irrigation Solution is FRO. This falls under the Anesthesiology category.

Other Devices by Innovacyn, Inc.

K232080Puracyn® Plus Antimicrobial Irrigation Solution

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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