Irrisept Antimicrobial Wound Lavage
K-Number: K240552 · 2024-06-18
ApplicantIrrimax Corporation
Decision Date2024-06-18
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
Irrisept Antimicrobial Wound Lavage is a medical device manufactured by Irrimax Corporation. It received FDA 510(k) clearance on 2024-06-18 under approval number K240552. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. 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 2024-06-18. It is manufactured by Irrimax Corporation. The 510(k) number is K240552.
When was Irrisept Antimicrobial Wound Lavage approved by the FDA?
Irrisept Antimicrobial Wound Lavage received FDA 510(k) clearance on 2024-06-18, under approval number K240552.
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 FRO. This falls under the Anesthesiology category.
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
Other Devices by Irrimax Corporation
Related Devices (Code: FRO)
K160695Talymed SuspensionMarine Polymer Technologies, Inc.
K160872PolyPlex Wound DressingGlobal Health Solutions, LLC
K161623Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mLB.Braun Medical, Inc.
K152533Xonrid GelHelsinn Healthcare SA
K152970Dynarex Xeroform Petrolatum DressingDynarex Corporation
K161212Atteris Antimicrobial Skin ProtectantRochal Industries, LLC
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.