FDA 510(k) Applications for Medical Device Product Code "EYB"
(Catheter, Ureteral, Gastro-Urology)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K043581 | ACMI CORPORATION | DUAL LUMEN CATHETER | 03/03/2005 |
| K030293 | AMSINO INTERNATIONAL, INC. | AMSURE RED RUBBER URETHRAL CATHETER | 02/04/2004 |
| K020577 | APPLIED MEDICAL RESOURCES CORP. | APPLIED URETERAL CATHETER | 05/22/2002 |
| K133750 | Boston Scientific Corporation | OCCLUDER OCCLUSION BALLOON CATHETER | 01/08/2014 |
| K032521 | C.R. BARD, INC. | BARD DUAL LUMEN URETERAL CATHETER | 11/14/2003 |
| K182122 | Coloplast Corp | Ureteric Catheters | 10/04/2018 |
| K171043 | Coloplast Corp | Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters | 12/21/2017 |
| K180182 | Cook Incorporated | Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter | 09/14/2018 |
| K182695 | Cook Incorporated | Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter | 06/17/2019 |
| K183323 | COOK Incorporated | UPJ Occlusion Balloon Catheter | 08/05/2019 |
| K962004 | COOK UROLOGICAL, INC. | AQ HYDROPHILIC UROLOGICAL CATHETERS | 06/11/1996 |
| K191187 | Dornier MedTech America Inc | Dornier MINNOW Ureteral Catheter | 09/18/2019 |
| K083788 | ENDO OPTIKS, INC. | ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR | 03/03/2009 |
| K033368 | FOSSA MEDICAL, INC. | FOSSA URETERAL OPEN LUMEN STENT | 11/26/2003 |
| K964899 | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH | KENDALL CURITY URETERAL CATHETER | 02/07/1997 |
| K092250 | MEDLINE INDUSTRIES, INC. | MEDLINE RED RUBBER URETHRAL CATHETER | 01/21/2010 |
| K021856 | PORGES S.A. | PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX | 10/17/2002 |
| K192183 | Promepal Sam | RocaTub Ureteral Catheter | 04/23/2020 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
