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FDA 510(k)

Irrisept Antimicrobial Wound Lavage

K-Number: K210536 · 2021-05-28

ApplicantIrrimax Corporation
Decision Date2021-05-28
Product CodeFQH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Irrisept Antimicrobial Wound Lavage is a medical device manufactured by Irrimax Corporation. It received FDA 510(k) clearance on 2021-05-28 under approval number K210536. 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 Antimicrobial Wound Lavage?

Irrisept Antimicrobial Wound Lavage is a medical device that received FDA 510(k) clearance on 2021-05-28. It is manufactured by Irrimax Corporation. The 510(k) number is K210536.

When was Irrisept Antimicrobial Wound Lavage approved by the FDA?

Irrisept Antimicrobial Wound Lavage received FDA 510(k) clearance on 2021-05-28, under approval number K210536.

What company makes Irrisept Antimicrobial Wound Lavage?

Irrisept Antimicrobial Wound Lavage is manufactured by Irrimax Corporation.

What is the FDA product code for Irrisept Antimicrobial Wound Lavage?

The FDA product code for Irrisept Antimicrobial Wound Lavage is FQH.

Related Clinical Trials

NCT07604636 Adjunctive Ozone Therapy for Residual Periodontal Pockets COMPLETED NCT07494773 Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection NOT_YET_RECRUITING NCT07099482 "Ultrasound-Enhanced Propolis Therapy for Healing Diabetic Foot Wounds" NOT_YET_RECRUITING NCT07551297 Ozone Therapy After Open Flap Debridement in Periodontitis COMPLETED NCT07066254 The Mepilex Cesarean Delivery Trial NOT_YET_RECRUITING NCT07321704 Effect of Antiseptic Irrigations With 0.05% Chlorhexidine Gluconate (Irrisept) Versus Normal Saline on Fasciocutaneous Flap-Based Closure of Pilonidal Disease RECRUITING

Related PubMed Literature

PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025)

Other Devices by Irrimax Corporation

K202222Irrisept Wound Debridement and Cleansing System K222804Irrisept Antimicrobial Wound Lavage K240552Irrisept Antimicrobial Wound Lavage

Related Devices (Code: FQH)

K161165Next Science Irrigation SolutionNext Science, LLC K202222Irrisept Wound Debridement and Cleansing SystemIrrimax Corporation K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC K192349Bactisure Wound LavageNext Science, LLC K221504BD Surgiphor™ Antimicrobial Irrigation SystemBd K222804Irrisept Antimicrobial Wound LavageIrrimax Corporation

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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