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FDA 510(k)

SKINCOTE

K-Number: K882567 · 1988-10-05

ApplicantDynarex Corp.
Decision Date1988-10-05
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

SKINCOTE is the device name listed in this FDA 510(k) record. The listed applicant is Dynarex Corp.. It received FDA 510(k) clearance on 1988-10-05 under 510(k) number K882567. 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 for Some Indications.

Frequently Asked Questions

What is the SKINCOTE?

SKINCOTE is a medical device that received FDA 510(k) clearance on 1988-10-05. The listed applicant is Dynarex Corp.. The 510(k) number is K882567.

When did SKINCOTE receive FDA 510(k) clearance?

SKINCOTE received FDA 510(k) clearance on 1988-10-05, under 510(k) number K882567.

Who is the listed applicant for SKINCOTE?

The FDA 510(k) record lists Dynarex Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKINCOTE?

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

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Other records listing Dynarex Corp. 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.

K052743DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921K052314DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGEK012816DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414K012957TOWEL DRAPE, MODELS 4409, 4410K012917DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-BK991694DYNAREX DRAIN SPONGE

View all 19 devices →

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, 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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