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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 the device name listed in this FDA 510(k) record. The listed applicant is Inopro, Inc.. It received FDA 510(k) clearance on 2022-05-31 under 510(k) 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. The listed applicant is Inopro, Inc.. The 510(k) number is K210987.

When did IRRIGO Wound Wash Jet System receive FDA 510(k) clearance?

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

Who is the listed applicant for IRRIGO Wound Wash Jet System?

The FDA 510(k) record lists Inopro, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: FQH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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