FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K103043 |
ADAPTA MEDICAL, INC |
COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH |
01/07/2011 |
K161445 |
ADAPTA MEDICAL, INC |
PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C |
08/16/2016 |
K181445 |
Amsino International Inc. |
AMSure Hydrophilic Intermittent Catheter |
10/01/2018 |
K091306 |
AMSINO INTERNATIONAL, INC. |
AMSURE PVC INTERMITTENT CATHETER |
08/21/2009 |
K113424 |
ASTRA TECH AB |
LOFRIC SINGLE USE URINARY CATHETER |
04/17/2012 |
K122078 |
ASTRA TECH, INC. |
LOFRIC PRIMO, LOFRIC HYDRO-KIT |
10/31/2012 |
K202566 |
Big Blue Biotech, Inc. |
Wiygul Catheter |
09/30/2020 |
K212430 |
Bonree Medical Co., Ltd |
BONREE Nelaton Catheter |
04/29/2022 |
K041464 |
BUSSE HOSPITAL DISPOSABLES |
BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER |
11/05/2004 |
K133470 |
C.R. BARD, INC. |
BARD RITECATH INTERMITTENT CATHETER |
04/04/2014 |
K142575 |
C.R. Bard, Inc. |
Bard RiteCath Intermittent Urinary Catheter |
10/31/2014 |
K112137 |
C.R. BARD, INC. |
COMFORTGLIDE INTERMITENT CATHETER |
08/26/2011 |
K150345 |
C.R. BARD, INC. |
Magic3 Go Intermittent Urinary Catheter |
05/11/2015 |
K172247 |
C.R. Bard, Inc. |
Magic3 Go Intermittent Urinary Catheter |
09/20/2017 |
K030538 |
CATHETER LLC. |
AMERICAN CATHETER, MODEL W3 |
03/10/2003 |
K212567 |
Chengdu Daxan Innovative Medical Tech. Co., Ltd |
PVC Hydrophilic Urethral Catheter |
12/07/2022 |
K230165 |
Coloplast |
Luja CoudΘ (20118 Male CH8 - small packaging (Pocket size)), Luja CoudΘ (20111 Male CH10 - small packaging (Pocket size)), Luja CoudΘ (20112 Male CH12 - small packaging (Pocket size)), Luja CoudΘ (20114 Male CH14 - small packaging (Pocket size)), Luja Cou |
08/25/2023 |
K221401 |
Coloplast |
Self-Cath and Self-Cath Plus |
12/02/2022 |
K210250 |
Coloplast |
SpeedCath Compact Male |
04/26/2022 |
K203637 |
Coloplast |
SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) |
03/08/2022 |
K222059 |
Coloplast |
SpeediCath Flex Set |
09/21/2022 |
K973070 |
COLOPLAST CORP. |
CONVEEN EASICATH SET |
11/06/1997 |
K100878 |
COLOPLAST MANUFACTURING US, LLC |
SELF CATH CATHETER |
05/26/2010 |
K140945 |
COMPACTCATH INC |
COMPACTCATH INTERMITTENT URINARY CATHETER |
08/22/2014 |
K160858 |
COMPACTCATH INC. |
CompactCath Intermittent Urinary Catheter |
04/26/2016 |
K180738 |
Compactcath, Inc. |
COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter |
06/14/2018 |
K221593 |
ConvaTec, Inc. |
Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus |
11/17/2022 |
K072539 |
CURE MEDICAL LLC. |
CURE CATHETER |
09/13/2007 |
K110653 |
CURE MEDICAL LLC. |
CURE CATHETER |
08/01/2011 |
K132500 |
CURE MEDICAL LLC. |
CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED |
12/23/2013 |
K211212 |
Dentsply Sirona |
LoFric Elle |
02/17/2022 |
K223756 |
Dentsply Sirona |
SimProÖ Now, GentleCathÖ Hydrophilic |
05/04/2023 |
K103086 |
DYNAREX CORPORATION |
DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC |
06/07/2011 |
K132619 |
FLEXICARE MEDICAL LTD. |
CLASSIC INTERMITTENT CATHETER |
10/11/2013 |
K090576 |
FOOTPRINT MEDICAL |
FOOTPRINT URINARY DRAINAGE CATHETER |
08/12/2009 |
K222677 |
Hangzhou Jimushi Meditech Co., Ltd. |
Intermittent nelaton catheter for single use |
04/05/2023 |
K213575 |
Hollister Incorporated |
Female IC (Not Finalized) |
09/13/2022 |
K220667 |
Hollister Incorporated |
Sleeved IC |
12/08/2022 |
K080007 |
ICU MEDICAL, INC |
GRADUATED ADAPTER WITH CLAVE |
05/13/2008 |
K973546 |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER |
11/07/1997 |
K172541 |
Medline Industries, Inc. |
Medline Catheter Specimen Collector |
02/22/2018 |
K100302 |
MEDLINE INDUSTRIES, INC. |
MEDLINE PVC URETHRAL CATHETER |
07/02/2010 |
K993226 |
MEMCATH TECHNOLOGIES LLC. |
MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006 |
12/10/1999 |
K050008 |
MENTOR CORP. |
MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER |
06/03/2005 |
K052440 |
MENTOR CORPORATION |
MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER |
10/11/2005 |
K072997 |
NEOMED, INC. |
NEOMED URINARY CATHETER |
12/19/2007 |
K062444 |
OASIS MEDIKAL URUNLER KIMYA SANAYI VE TIC A.S. |
HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT |
02/22/2007 |
K040519 |
PERCUTANEOUS SYSTEMS, INC. |
SLIP UROLOGY CATHETER |
05/20/2004 |
K061766 |
PERCUTANEOUS SYSTEMS, INCORPORATED |
EXPRESSWAY INTERMITTENT CATHETER |
03/09/2007 |
K122785 |
ROCHESTER MEDICAL CORP. |
HYDROSIL; MAGIC; PERSONAL CATHETER |
05/14/2013 |
K151745 |
SHAOXING FUQING HEALTH PRODUCTS CO., LTD. |
FULL CARE Disposable PVC Nelaton Catheter |
03/03/2016 |
K023872 |
VITALCARE, INC. |
VITALCARE URETHRAL CATHETER RED RUBBER |
04/10/2003 |
K133615 |
WELL LEAD MEDICAL CO. LTD |
WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER |
02/24/2014 |
K220722 |
Well Lead Medical Co., Ltd. |
PVC Hydrophilic Urethral Catheter |
05/22/2023 |
K142563 |
WELL LEAD MEDICAL CO., LTD. |
Well Lead PVC Urethral Catheter |
10/28/2014 |
K123751 |
WELLSPECT HEALTHCARE |
LOFRIC SENSE |
02/28/2013 |
K170233 |
Zhanjiang Star Enterprise Co., Ltd |
Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) |
10/13/2017 |