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FDA 510(k)

IRRIGO Wound Wash Jet System

K-Number: K210987 · 2022-05-31

ApplicantInopro, Inc.
Decision Date2022-05-31
Product CodeFQH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IRRIGO Wound Wash Jet System is a medical device manufactured by Inopro, Inc.. It received FDA 510(k) clearance on 2022-05-31 under approval number K210987. 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 IRRIGO Wound Wash Jet System?

IRRIGO Wound Wash Jet System is a medical device that received FDA 510(k) clearance on 2022-05-31. It is manufactured by Inopro, Inc.. The 510(k) number is K210987.

When was IRRIGO Wound Wash Jet System approved by the FDA?

IRRIGO Wound Wash Jet System received FDA 510(k) clearance on 2022-05-31, under approval number K210987.

What company makes IRRIGO Wound Wash Jet System?

IRRIGO Wound Wash Jet System is manufactured by Inopro, Inc..

What is the FDA product code for IRRIGO Wound Wash Jet System?

The FDA product code for IRRIGO Wound Wash Jet System is FQH.

Related Clinical Trials

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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)

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Official Source

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