Cleared Traditional

Fluent Fluid Management System

K180825 · Hologic, Inc. · Obstetrics & Gynecology
Aug 2018
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K180825 is an FDA 510(k) clearance for the Fluent Fluid Management System, a Insufflator, Hysteroscopic (Class II — Special Controls, product code HIG), submitted by Hologic, Inc. (Marlborough, US). The FDA issued a Cleared decision on August 3, 2018, 126 days after receiving the submission on March 30, 2018. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1700.

Submission Details

510(k) Number K180825 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2018
Decision Date August 03, 2018
Days to Decision 126 days
Submission Type Traditional
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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