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FDA 510(k)

SilverSeal

K-Number: K171041 · 2017-08-22

ApplicantAlliqua Biomedical, Inc.
Decision Date2017-08-22
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SilverSeal is the device name listed in this FDA 510(k) record. The listed applicant is Alliqua Biomedical, Inc.. It received FDA 510(k) clearance on 2017-08-22 under 510(k) number K171041. 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 SilverSeal?

SilverSeal is a medical device that received FDA 510(k) clearance on 2017-08-22. The listed applicant is Alliqua Biomedical, Inc.. The 510(k) number is K171041.

When did SilverSeal receive FDA 510(k) clearance?

SilverSeal received FDA 510(k) clearance on 2017-08-22, under 510(k) number K171041.

Who is the listed applicant for SilverSeal?

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

What is the FDA product code for SilverSeal?

The FDA product code for SilverSeal is FRO. This falls under the Anesthesiology category.

Other records listing Alliqua Biomedical, 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.

K162721Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator

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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