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FDA 510(k)

VASHE WOUND CLEANSING SYSTEM

K-Number: K060901 · 2006-06-29

ApplicantSterilox Technologies, Inc.
Decision Date2006-06-29
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

VASHE WOUND CLEANSING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sterilox Technologies, Inc.. It received FDA 510(k) clearance on 2006-06-29 under 510(k) number K060901. 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 VASHE WOUND CLEANSING SYSTEM?

VASHE WOUND CLEANSING SYSTEM is a medical device that received FDA 510(k) clearance on 2006-06-29. The listed applicant is Sterilox Technologies, Inc.. The 510(k) number is K060901.

When did VASHE WOUND CLEANSING SYSTEM receive FDA 510(k) clearance?

VASHE WOUND CLEANSING SYSTEM received FDA 510(k) clearance on 2006-06-29, under 510(k) number K060901.

Who is the listed applicant for VASHE WOUND CLEANSING SYSTEM?

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

What is the FDA product code for VASHE WOUND CLEANSING SYSTEM?

The FDA product code for VASHE WOUND CLEANSING SYSTEM is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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.

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Other records listing Sterilox Technologies, 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.

K013280STERILOX LIQUID CHEMICAL STERILANT SYSTEM

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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