Cleared Special

Aquilex Fluid Control System AQL-100S

K172040 · W.O.M. World of Medicine GmbH · Obstetrics & Gynecology
Feb 2018
Decision
215d
Days
Class 2
Risk

About This 510(k) Submission

K172040 is an FDA 510(k) clearance for the Aquilex Fluid Control System AQL-100S, a Insufflator, Hysteroscopic (Class II — Special Controls, product code HIG), submitted by W.O.M. World of Medicine GmbH (Berlin, DE). The FDA issued a Cleared decision on February 5, 2018, 215 days after receiving the submission on July 5, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1700.

Submission Details

510(k) Number K172040 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2017
Decision Date February 05, 2018
Days to Decision 215 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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