FDA 510(k) Applications for Medical Device Product Code "HHW"
(Pessary, Vaginal)

FDA 510(k) Number Applicant Device Name Decision Date
K032644 ADAMED LTD. KOLPEXIN SPHERE 05/28/2004
K013289 BIOTEQUE AMERICA, INC. BIOTEQUE VAGINAL PESSARIES 12/27/2001
K060526 CONTIPI LTD. TIPI 06/09/2006
K131198 CONTIPI LTD. TIPI OTC 08/27/2013
K190277 ConTIPI Medical Ltd. ProVate Vaginal Support 07/08/2019
K974117 DESCHUTES MEDICAL PRODUCTS, INC. PELVX DONUT, PELVX CUBE 04/27/1998
K002329 DESCHUTES MEDICAL PRODUCTS, INC. PELVX GELLHORN VAGINAL PESSARY 603-608 09/18/2000
K990593 DESCHUTES MEDICAL PRODUCTS, INC. PELVX INCONTINENCE DISH, MODEL 301-306 05/24/1999
K974116 DESCHUTES MEDICAL PRODUCTS, INC. PELVX INCONTINENCE RING 04/27/1998
K974115 DESCHUTES MEDICAL PRODUCTS, INC. PELVX RING, PELVX RING WITH SUPPORT 04/27/1998
K083769 EASTMED INC. MODIFICATION TO URESTA PESSARY 01/14/2009
K081385 EASTMED INC. URESTA PESSARY 10/09/2008
K132313 EIS CORPORATION PESSARY 12/05/2014
K965040 JOHNSON & JOHNSON MEDICAL, INC. INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL 03/10/1997
K031463 MARINA MEDICAL INSTRUMENTS, INC. MARINA MEDICAL SILICONE PESSARY 11/18/2003
K020512 MEDICAL TECHNOLOGY AND INNOVATIONS, INC. MTI ST#1 SILICONE PESSARY 05/16/2002
K993308 MENTOR CORP. MENTOR EVACARE VAGINAL PESSARIES 12/13/1999
K153422 Panpac Medical Corporation Panpac Disposable Pessary Fitting Set 07/14/2016
K173351 Panpac Medical Corporation Panpac Flexi Shelf Pessary 10/31/2018
K132670 Panpac Medical Corporation PANPAC INFLATABLE DOCUT PESSARY 06/04/2014
K092981 Panpac Medical Corporation PANPAC VAGINAL PESSARY 07/22/2010
K151413 PROCTER & GAMBLE Always/Tampax bladder supports 12/18/2015
K183468 Rinovum Subsidiary 2, LLC Revive Reusable Bladder Support 01/25/2019
K012277 SIMS PORTEX LTD. PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE 02/11/2002


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