Register, a Disposable Hysterography Cupula

FDA 510(k) K894259 · Washington Regulatory Services

Substantially Equivalent

510(k) numberK894259

Submission

Device name
Register, a Disposable Hysterography Cupula
Applicant
Washington Regulatory Services
Ringoes, NJ, US
Received
June 20, 1989
Decision date
March 5, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HIG – Insufflator, Hysteroscopic
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1700
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HIG

510(k)DeviceApplicantDecision
K261706Endomat Select (UP220)HIG · Traditional Karl Storz Se & Co. KG07/16/2026SE
K251273Asurys Fluid Management SystemHIG · Traditional Boston Scientific Corporation03/27/2026SE
K240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System…HIG · Traditional Hologic, Inc.07/25/2024SE
K210628X-FLO Fluid Management SystemHIG · Traditional Thermedx, LLC11/04/2021SE
K201355Endomat Select, IBS Shaver Software, LicenseHIG · Special Karl Storz SE & CO. KG07/22/2020SE
K180735Endomat SelectHIG · Traditional Karl Storz SE & CO. KG10/31/2018SE
K180825Fluent Fluid Management SystemHIG · Traditional Hologic, Inc.08/03/2018SE
K173489GYN-Pump PH304HIG · Traditional W.O.M. World of Medicine GmbH03/28/2018SE
K172040Aquilex Fluid Control System AQL-100SHIG · Special W.O.M. World of Medicine GmbH02/05/2018SE
K172048FluidSmartHIG · Special Thermedx, LLC09/05/2017SE

More from Thermedx, LLC

510(k)DeviceDecision
K983604Intra-Uterine Transfer, Intra-Folopian TransferMQF · Traditional 05/27/1999SE
K882658Angioscope for Pulmonary Artery UseDQO · Traditional 01/26/1989SE

Questions and answers

When was Register, a Disposable Hysterography Cupula cleared by the FDA?

Register, a Disposable Hysterography Cupula (K894259) received a 510(k) decision of Substantially Equivalent on March 5, 1990, 258 days after the submission was received.

What is the product code of K894259?

The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.