FDA 510(k)

LUOFUCON Silicone Ag foam dressing

K-Number: K160022 · 2016-08-17

ApplicantHuizhou Foryou Medical Devices Co., Ltd.

Decision Date2016-08-17

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

LUOFUCON Silicone Ag foam dressing is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2016-08-17 under 510(k) number K160022. 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 LUOFUCON Silicone Ag foam dressing?

LUOFUCON Silicone Ag foam dressing is a medical device that received FDA 510(k) clearance on 2016-08-17. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K160022.

When did LUOFUCON Silicone Ag foam dressing receive FDA 510(k) clearance?

LUOFUCON Silicone Ag foam dressing received FDA 510(k) clearance on 2016-08-17, under 510(k) number K160022.

Who is the listed applicant for LUOFUCON Silicone Ag foam dressing?

The FDA 510(k) record lists Huizhou Foryou Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUOFUCON Silicone Ag foam dressing?

The FDA product code for LUOFUCON Silicone Ag foam dressing is FRO. This falls under the Anesthesiology category.

Other records listing Huizhou Foryou Medical Devices Co., Ltd. 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.

K250642LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)K240809LUOFUCON® Silver Collagen Dressing K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)K240485LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)K232796LUOFUCON® Collagen Particles (Collagen Wound Dressing)K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing

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Related Devices (Code: FRO)

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC K261023Microdacyn 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.