FDA.reportPublic FDA data

510(k) K894259

Device
REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA
Applicant
WASHINGTON REGULATORY SERVICES
510(k) number
K894259
Product code
HIG  
Decision
Substantially Equivalent (SESE)
Decision date
1990-03-05
Date received
1989-06-20
Regulation
884.1700
Classification name
Insufflator, Hysteroscopic
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RANDOLPH COOKE
Address
R.D. #3 Box 237 Welisewitz Rd. Ringoes NJ US 08551 08551

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases