Jimushi Sterile Urethral Catheter for single use

FDA 510(k) K200134 · Hangzhou Jimushi Meditech Co., Ltd.

Substantially Equivalent

510(k) numberK200134

Submission

Device name
Jimushi Sterile Urethral Catheter for single use
Applicant
Hangzhou Jimushi Meditech Co., Ltd.
Hangzhou, CN
Received
January 21, 2020
Decision date
June 1, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GBM – Catheter, Urethral
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Specialty
Gastroenterology, Urology

Other 510(k)s with product code GBM

510(k)DeviceApplicantDecision
K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic…GBM · Traditional Well Lead Medical Co., Ltd.03/05/2025SE
K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterGBM · Traditional Convatec Limited06/22/2022SE
K211436Intermittent Catheter (Not Finalized)GBM · Traditional Hollister Incorporated01/27/2022SE
K200820SpeediCath Compact SetGBM · Traditional Coloplast11/13/2020SE
K192904SpeediCath Compact SetGBM · Traditional Coloplast11/02/2020SE
K200142SpeediCath SoftGBM · Traditional Coloplast07/30/2020SE
K191512LotusCatheter (Lotus No Balloon Catheter)GBM · Traditional Hakki Medical Technologies, Inc.05/21/2020SESK
K192577Actreen Hi-Lite Intermittent Urinary CathetersGBM · Special B.Braun Medical, Inc.05/07/2020SE
K193148VaPro Plus Pocket, VaPro PlusGBM · Special Hollister Incorporated12/13/2019SE
K192468Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use…GBM · Traditional Hangzhou Bever Medical Devices Co., Ltd.11/27/2019SE

More from Hangzhou Bever Medical Devices Co., Ltd.

510(k)DeviceDecision
K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)EZD · Traditional 06/24/2026SE
K222677Intermittent nelaton catheter for single useEZD · Traditional 04/05/2023SE

Questions and answers

When was Jimushi Sterile Urethral Catheter for single use cleared by the FDA?

Jimushi Sterile Urethral Catheter for single use (K200134) received a 510(k) decision of Substantially Equivalent on June 1, 2020, 132 days after the submission was received.

What is the product code of K200134?

The FDA product code is GBM – Catheter, Urethral, a Class II (moderate risk) device regulated under 21 CFR 876.5130.