Guardiancatheter-Urinary Drainage Catheter

FDA 510(k) K063795 · Marian Medical, Inc.

Substantially Equivalent

510(k) numberK063795

Submission

Device name
Guardiancatheter-Urinary Drainage Catheter
Applicant
Marian Medical, Inc.
Louisville, KY, US
Received
December 22, 2006
Decision date
March 5, 2007
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
K200134Jimushi Sterile Urethral Catheter for single useGBM · Traditional Hangzhou Jimushi Meditech Co., Ltd.06/01/2020SE
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

More from Hollister Incorporated

510(k)DeviceDecision
K070048Guardian Catheter-Infant Urinary Collection KitFCM · Traditional 03/15/2007SE
K050542Marian Infant Feeding Tube (Guardianpicc Percutaneous Central Venous CatheterLJS · Traditional 07/26/2005SE
K042112Infant Feeding TubeKNT · Traditional 01/28/2005SE

Questions and answers

When was Guardiancatheter-Urinary Drainage Catheter cleared by the FDA?

Guardiancatheter-Urinary Drainage Catheter (K063795) received a 510(k) decision of Substantially Equivalent on March 5, 2007, 73 days after the submission was received.

What is the product code of K063795?

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