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FDA 510(k)

Next Science Wound Gel (Rx)

K-Number: K163188 · 2017-03-06

ApplicantNext Science, LLC
Decision Date2017-03-06
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Next Science Wound Gel (Rx) is the device name listed in this FDA 510(k) record. The listed applicant is Next Science, LLC. It received FDA 510(k) clearance on 2017-03-06 under 510(k) number K163188. 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 Next Science Wound Gel (Rx)?

Next Science Wound Gel (Rx) is a medical device that received FDA 510(k) clearance on 2017-03-06. The listed applicant is Next Science, LLC. The 510(k) number is K163188.

When did Next Science Wound Gel (Rx) receive FDA 510(k) clearance?

Next Science Wound Gel (Rx) received FDA 510(k) clearance on 2017-03-06, under 510(k) number K163188.

Who is the listed applicant for Next Science Wound Gel (Rx)?

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

What is the FDA product code for Next Science Wound Gel (Rx)?

The FDA product code for Next Science Wound Gel (Rx) is FRO. This falls under the Anesthesiology category.

Other records listing Next Science, LLC 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.

K203446TorrentX Wound WashK203835MIS SolutionK192349Bactisure Wound LavageK161165Next Science 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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