Cleared Special

FluidSmart

K172048 · Thermedx, LLC · Obstetrics & Gynecology
Sep 2017
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K172048 is an FDA 510(k) clearance for the FluidSmart, a Insufflator, Hysteroscopic (Class II — Special Controls, product code HIG), submitted by Thermedx, LLC (Solon, US). The FDA issued a Cleared decision on September 5, 2017, 61 days after receiving the submission on July 6, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1700.

Submission Details

510(k) Number K172048 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2017
Decision Date September 05, 2017
Days to Decision 61 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HIG — Insufflator, Hysteroscopic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1700

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