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FDA 510(k)

Puracyn® Plus Antimicrobial Irrigation Solution

K-Number: K232080 · 2024-05-31

ApplicantInnovacyn, Inc.
Decision Date2024-05-31
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Puracyn® Plus Antimicrobial Irrigation Solution is the device name listed in this FDA 510(k) record. The listed applicant is Innovacyn, Inc.. It received FDA 510(k) clearance on 2024-05-31 under 510(k) number K232080. 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 2024-05-31. The listed applicant is Innovacyn, Inc.. The 510(k) number is K232080.

When did Puracyn® Plus Antimicrobial Irrigation Solution receive FDA 510(k) clearance?

Puracyn® Plus Antimicrobial Irrigation Solution received FDA 510(k) clearance on 2024-05-31, under 510(k) number K232080.

Who is the listed applicant for Puracyn® Plus Antimicrobial Irrigation Solution?

The FDA 510(k) record lists Innovacyn, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Innovacyn, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251757Puracyn® Plus Antimicrobial Irrigation Solution

Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, Inc.

Official Source

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

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