Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005706359

FEI Number

3005706359

Entity Name

IRRIMAX CORPORATION

City/State/Country

Lawrenceville, GA, US

Establishment Address

1665 Lakes Parkway, Suite 102, Lawrenceville, GA 30043, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

IRRIMAX CORPORATION (Owner Number: 9086561)

Owner / Operator Contact Address

1665 Lakes Parkway, Suite 102, Lawrenceville, GA 30043, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240552

PMA Number

N/A

All Registered Proprietary Names

Irrisept Antimicrobial Wound Lavage Irrisept Antimicrobial Wound Lavage Irrisept Antimicrobial Wound Lavage, Accessories Kit Irrisept Antimicrobial Wound Lavage, Wound Solution Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2022-10-27
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2022-10-27
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2022-08-25
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2022-08-25
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-06-26

Official Correspondent

Richard Holecek

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

IRRIMAX CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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3009217531	Eurofins STERIPAC GMBH	Calw-Altburg Baden-Wurttemberg, DE
1718850	LivaNova USA, INC.	ARVADA, CO, US
3045076544	BEIJING YUEWEI MEDICAL TECHNOLOGY CO., LTD	Beijing, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005706359. Last updated year: 2026. Please use registration number 3005706359 when referencing this establishment in official correspondence.