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FDA 510(k)

Irrisept Wound Debridement and Cleansing System

K-Number: K202222 · 2020-12-14

ApplicantIrrimax Corporation
Decision Date2020-12-14
Product CodeFQH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Irrisept Wound Debridement and Cleansing System is a medical device manufactured by Irrimax Corporation. It received FDA 510(k) clearance on 2020-12-14 under approval number K202222. 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 Debridement and Cleansing System?

Irrisept Wound Debridement and Cleansing System is a medical device that received FDA 510(k) clearance on 2020-12-14. It is manufactured by Irrimax Corporation. The 510(k) number is K202222.

When was Irrisept Wound Debridement and Cleansing System approved by the FDA?

Irrisept Wound Debridement and Cleansing System received FDA 510(k) clearance on 2020-12-14, under approval number K202222.

What company makes Irrisept Wound Debridement and Cleansing System?

Irrisept Wound Debridement and Cleansing System is manufactured by Irrimax Corporation.

What is the FDA product code for Irrisept Wound Debridement and Cleansing System?

The FDA product code for Irrisept Wound Debridement and Cleansing System is FQH.

Related Clinical Trials

NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT07607106 Efficacy of a New Composition (BU002) for Debridement of Chronic Cutaneous Ulcers RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07600489 A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers NOT_YET_RECRUITING NCT06149650 Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study RECRUITING NCT03404895 The Mount Sinai Diabetic Foot Ulcer Prospective Trial WITHDRAWN

Related PubMed Literature

PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025)

Other Devices by Irrimax Corporation

K210536Irrisept Antimicrobial Wound Lavage K222804Irrisept Antimicrobial Wound Lavage K240552Irrisept Antimicrobial Wound Lavage

Related Devices (Code: FQH)

K161165Next Science Irrigation SolutionNext Science, LLC K202071SURGIPHOR Wound Irrigation SystemOrthophor, LLC K192349Bactisure Wound LavageNext Science, LLC K210536Irrisept Antimicrobial Wound LavageIrrimax Corporation 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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