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FDA 510(k)

IRRISEPT WOUND CLEANSING SYSTEM

K-Number: K080779 · 2009-02-04

ApplicantIrrimax Corporation
Decision Date2009-02-04
Product CodeFQH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IRRISEPT WOUND CLEANSING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Irrimax Corporation. It received FDA 510(k) clearance on 2009-02-04 under 510(k) number K080779. The device is classified under product code FQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRISEPT WOUND CLEANSING SYSTEM?

IRRISEPT WOUND CLEANSING SYSTEM is a medical device that received FDA 510(k) clearance on 2009-02-04. The listed applicant is Irrimax Corporation. The 510(k) number is K080779.

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

IRRISEPT WOUND CLEANSING SYSTEM received FDA 510(k) clearance on 2009-02-04, under 510(k) number K080779.

Who is the listed applicant for IRRISEPT WOUND CLEANSING SYSTEM?

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

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

The FDA product code for IRRISEPT WOUND CLEANSING SYSTEM is FQH.

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Other records listing Irrimax Corporation 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.

K240552Irrisept Antimicrobial Wound LavageK222804Irrisept Antimicrobial Wound LavageK210536Irrisept Antimicrobial Wound LavageK202222Irrisept Wound Debridement and Cleansing System

Related Devices (Code: FQH)

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.

K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)Becton, Dickinson and Company (BD)K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)BdK231023ERBEJET® 2 SystemErbe Elektromedizin GmbHK220759Armis VeriCyn Wound WashArmis Biopharma, Inc.K220964VERSAJET Hydrosurgery System (III)Smith & Nephew Medical LimitedK221504BD Surgiphor™ Antimicrobial Irrigation SystemBd

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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