Who is the manufacturer of HYSTALOG HSG CATHETER?

Rocket Medical Plc submitted the Traditional clearance for HYSTALOG HSG CATHETER (K000340).

What is the FDA product code for HYSTALOG HSG CATHETER?

HES. It is classified under 21 CFR 884.1300 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for HYSTALOG HSG CATHETER?

510(k) clearance (submission type: Traditional).

HYSTALOG HSG CATHETER

K000340 · Rocket Medical Plc · HES · Apr 19, 2000 · Obstetrics/Gynecology

Device Facts

Record ID	K000340
Device Name	HYSTALOG HSG CATHETER
Applicant	Rocket Medical Plc
Product Code	HES · Obstetrics/Gynecology
Decision Date	Apr 19, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.1300
Device Class	Class 2

Regulatory Classification

Identification

A uterotubal carbon dioxide insufflator and accessories is a device used to test the patency (lack of obstruction) of the fallopian tubes by pressurizing the uterus and fallopian tubes and filling them with carbon dioxide gas.