Cleared Traditional

THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000

K091939 · Thermedx, LLC · Obstetrics & Gynecology
Jul 2010
Decision
388d
Days
Class 2
Risk

About This 510(k) Submission

K091939 is an FDA 510(k) clearance for the THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000, a Insufflator, Hysteroscopic (Class II — Special Controls, product code HIG), submitted by Thermedx, LLC (Solon, US). The FDA issued a Cleared decision on July 23, 2010, 388 days after receiving the submission on June 30, 2009. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1700.

Submission Details

510(k) Number K091939 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2009
Decision Date July 23, 2010
Days to Decision 388 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

Similar Devices — HIG Insufflator, Hysteroscopic

All 54
Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)
K240886 · Hologic, Inc. · Jul 2024
X-FLO Fluid Management System
K210628 · Thermedx, LLC · Nov 2021
Endomat Select, IBS Shaver Software, License
K201355 · Karl Storz SE & CO. KG · Jul 2020
Endomat Select
K180735 · Karl Storz SE & CO. KG · Oct 2018
Fluent Fluid Management System
K180825 · Hologic, Inc. · Aug 2018
GYN-Pump PH304
K173489 · W.O.M. World of Medicine GmbH · Mar 2018