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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 a medical device manufactured by B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2017-05-23 under approval 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. It is manufactured by B.Braun Medical, Inc.. The 510(k) number is K163430.

When was Prontosan Wound Gel approved by the FDA?

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

What company makes Prontosan Wound Gel?

Prontosan Wound Gel is manufactured by B.Braun Medical, Inc..

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.

Other Devices by B.Braun Medical, Inc.

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Related Devices (Code: FRO)

K160695Talymed SuspensionMarine Polymer Technologies, Inc. K160872PolyPlex Wound DressingGlobal Health Solutions, LLC K161623Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mLB.Braun Medical, Inc. K152533Xonrid GelHelsinn Healthcare SA K152970Dynarex Xeroform Petrolatum DressingDynarex Corporation K161212Atteris Antimicrobial Skin ProtectantRochal Industries, LLC

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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