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510(k) K933384

Device
BARD HYSTERO-FLO II PUMP
Applicant
DAVOL, INC., SUB. C.R. BARD, INC.
510(k) number
K933384
Product code
HIG  
Decision
Substantially Equivalent (SESE)
Decision date
1994-12-30
Date received
1993-07-12
Regulation
884.1700
Classification name
Insufflator, Hysteroscopic
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAVID W MULLIS
Address
100 Sockanossett Crossroad Canston RI US 02920 02920

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HIG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251273Asurys Fluid Management SystemBoston Scientific Corporation2026-03-27
K240886Fluent 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)Hologic, Inc.2024-07-25
K210628X-FLO Fluid Management SystemThermedx, LLC2021-11-04
K201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG2020-07-22
K180735Endomat SelectKarl Storz SE & CO. KG2018-10-31
K180825Fluent Fluid Management SystemHologic, Inc.2018-08-03
K173489GYN-Pump PH304W.O.M. World of Medicine GmbH2018-03-28
K172040Aquilex Fluid Control System AQL-100SW.O.M. World of Medicine GmbH2018-02-05
K172048FluidSmartThermedx, LLC2017-09-05
K133799THERMEDX FLUID MANAGMENT SYSTEMThermedx, LLC2014-06-20
K123732HYSTEROSCOPY PUMP HM6W.O.M. World of Medicine AG2013-04-04
K112642AQUILEX FLUID CONTROL SYSTEM H112W.O.M. World of Medicine AG2012-02-06
K110852DOLPHIN 3 FLUID MANAGEMENT SYSTEMGyrus Acmi, Inc.2011-07-19
K091939THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000Thermedx, LLC2010-07-23
K031616IUR FLUID MANAGEMENT SYSTEMW.O.M. World of Medicine AG2003-08-13

Legacy Summary#

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FDA Review#

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