Adi Catheter with Valve

FDA 510(k) K952924 · Asia Dynamics, Inc.

Substantially Equivalent

510(k) numberK952924

Submission

Device name
Adi Catheter with Valve
Applicant
Asia Dynamics, Inc.
Niles, IL, US
Received
June 26, 1995
Decision date
August 18, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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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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
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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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K953500Hemo-BarrierKMF · Traditional 01/24/1996SE
K953501Adi Sterile Gauze SpongesEFQ · Traditional 08/28/1995SE
K891160Mic Non-Sterile Latex GlovesLYY · Traditional 10/13/1989SE

Questions and answers

When was Adi Catheter with Valve cleared by the FDA?

Adi Catheter with Valve (K952924) received a 510(k) decision of Substantially Equivalent on August 18, 1995, 53 days after the submission was received.

What is the product code of K952924?

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