X-FLO Fluid Management System

Insufflator, Hysteroscopic

Thermedx, LLC

The following data is part of a premarket notification filed by Thermedx, Llc with the FDA for X-flo Fluid Management System.

Pre-market Notification Details

Device IDK210628
510k NumberK210628
Device Name:X-FLO Fluid Management System
ClassificationInsufflator, Hysteroscopic
Applicant Thermedx, LLC 31200 Solon Rd Unit 1 Solon,  OH  44139
ContactDaniel Marijian
CorrespondentDaniel Marijian
Thermedx, LLC 31200 Solon Rd Unit 1 Solon,  OH  44139
Product CodeHIG  
Subsequent Product CodeHRX
Subsequent Product CodeLGZ
CFR Regulation Number884.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-02
Decision Date2021-11-04

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