510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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IrriMAX Corporation

Lawrenceville, GA, US

IRRIMAX CORPORATION appears in FDA device records in Lawrenceville, GA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
5
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 5 510(k) clearances for IrriMAX Corporation between 2009 and 2024. The busiest year on record is 2009, with 1. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for IrriMAX Corporation, by decision year
YearClearances
20091
20201
20211
20221
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K240552Irrisept Antimicrobial Wound LavageFROSubstantially Equivalent
K222804Irrisept Antimicrobial Wound LavageFQHSubstantially Equivalent
K210536Irrisept Antimicrobial Wound LavageFQHSubstantially Equivalent
K202222Irrisept Wound Debridement and Cleansing SystemFQHSubstantially Equivalent
K080779IRRISEPT WOUND CLEANSING SYSTEMFQHSubstantially Equivalent

Registered establishments

FDA registered establishments for IrriMAX Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30057063593005706359IRRIMAX CORPORATION1665 Lakes Parkway, Lawrenceville, GA 30043 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0191-2020Irrisept Wound Debridement and Cleansing System. 12 units per case.Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain