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FDA 510(k)

MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014

K-Number: K092232 · 2009-08-19

ApplicantPuricore, Inc.
Decision Date2009-08-19
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014 is the device name listed in this FDA 510(k) record. The listed applicant is Puricore, Inc.. It received FDA 510(k) clearance on 2009-08-19 under 510(k) number K092232. 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 MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014?

MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014 is a medical device that received FDA 510(k) clearance on 2009-08-19. The listed applicant is Puricore, Inc.. The 510(k) number is K092232.

When did MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014 receive FDA 510(k) clearance?

MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014 received FDA 510(k) clearance on 2009-08-19, under 510(k) number K092232.

Who is the listed applicant for MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014?

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

What is the FDA product code for MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014?

The FDA product code for MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014 is FRO. This falls under the Anesthesiology category.

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Other records listing Puricore, 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.

K123072VASHE WOUND THERAPY SOLUTIONK123071VASHE SKIN AND WOUND HYDROGELK100918VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014K093697VASHE WOUND THERAPY SOLUTIONK093155VASHE WOUND CLEANSING SYSTEMK063159STERILOX LIQUID CHEMICAL STERILANT SYSTEM

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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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