Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,

FDA 510(k) K090960 · Hollister, Inc.

Substantially Equivalent

510(k) numberK090960

Submission

Device name
Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,
Applicant
Hollister, Inc.
Libertyville, IL, US
Received
April 6, 2009
Decision date
August 20, 2009
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

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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

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K251468Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not…EZD · Traditional 10/03/2025SE
K233524Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not…EZD · Traditional 05/03/2024SE
K220667Sleeved ICEZD · Traditional 12/08/2022SE
K213575Female IC (Not Finalized)EZD · Traditional 09/13/2022SE
K211436Intermittent Catheter (Not Finalized)GBM · Traditional 01/27/2022SE
K193148VaPro Plus Pocket, VaPro PlusGBM · Special 12/13/2019SE
K191633Infyna ChicGBM · Special 07/19/2019SE
K183253ValPro 2 Plus, VaPro 2 Plus PocketGBM · Special 12/18/2018SE
K180824VaPro 2 Intermittent CatheterGBM · Special 06/22/2018SE

Questions and answers

When was Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, cleared by the FDA?

Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, (K090960) received a 510(k) decision of Substantially Equivalent on August 20, 2009, 136 days after the submission was received.

What is the product code of K090960?

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