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FDA 510(k)

URGOCLEAN ABSORBENT WOUND DRESSING

K-Number: K123219 · 2013-03-18

ApplicantLaboratoires Urgo
Decision Date2013-03-18
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

URGOCLEAN ABSORBENT WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Laboratoires Urgo. It received FDA 510(k) clearance on 2013-03-18 under 510(k) number K123219. 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 URGOCLEAN ABSORBENT WOUND DRESSING?

URGOCLEAN ABSORBENT WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2013-03-18. The listed applicant is Laboratoires Urgo. The 510(k) number is K123219.

When did URGOCLEAN ABSORBENT WOUND DRESSING receive FDA 510(k) clearance?

URGOCLEAN ABSORBENT WOUND DRESSING received FDA 510(k) clearance on 2013-03-18, under 510(k) number K123219.

Who is the listed applicant for URGOCLEAN ABSORBENT WOUND DRESSING?

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

What is the FDA product code for URGOCLEAN ABSORBENT WOUND DRESSING?

The FDA product code for URGOCLEAN ABSORBENT WOUND DRESSING is FRO. This falls under the Anesthesiology category.

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Other records listing Laboratoires Urgo 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.

K100429URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVERK100430URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVERK062559URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVERK061220URGOTUL AG

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

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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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