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FDA 510(k)

Prontosan Wound Gel

K-Number: K163430 · 2017-05-23

ApplicantB.Braun Medical, Inc.
Decision Date2017-05-23
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Prontosan Wound Gel is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2017-05-23 under 510(k) number K163430. 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 Prontosan Wound Gel?

Prontosan Wound Gel is a medical device that received FDA 510(k) clearance on 2017-05-23. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K163430.

When did Prontosan Wound Gel receive FDA 510(k) clearance?

Prontosan Wound Gel received FDA 510(k) clearance on 2017-05-23, under 510(k) number K163430.

Who is the listed applicant for Prontosan Wound Gel?

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

What is the FDA product code for Prontosan Wound Gel?

The FDA product code for Prontosan Wound Gel is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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.

NCT07275307Impact of Prontosan Wound Gel X on Surgical Site Infections in Cardiac SurgeryRECRUITING

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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

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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