Search Results
Found 1 results
510(k) Data Aggregation
K Number
K210987Device Name
IRRIGO Wound Wash Jet System
Manufacturer
Inopro Inc
Date Cleared
2022-05-31
(425 days)
Product Code
FQH, FRO
Regulation Number
880.5475Why did this record match?
Applicant Name (Manufacturer) :
Inopro Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IRRIGO Wound Wash Jet System is intended for use by or under the direction of a professional healthcare provider in moistening and lubricating absorbent wound dressings, cleansing, and maintaining a moist wound environment for traumatic wounds such as pressure sores, leg ulcers of diabetic and vascular origin, cuts, abrasions, and minor burns.
Device Description
IRRIGO Wound Wash Jet System is a sterile single patient use jet lavage medical device that consists of 0.9% USP Sodium Chloride solubilized in USP Purified Water for Irrigation and packaged in a food grade compressible translucent LDPE 2oz (60mL) bottle with a LPDE luer-lock type tip spray insert and an HPDE colored cap.
Ask a Question
Page 1 of 1