Product code EYB
- Device name
- Catheter, Ureteral, Gastro-Urology
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5130
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192183 | RocaTub Ureteral Catheter | Promepal Sam | 2020-04-23 |
| K191187 | Dornier MINNOW Ureteral Catheter | Dornier Medtech America, Inc. | 2019-09-18 |
| K183323 | UPJ Occlusion Balloon Catheter | Cook Incorporated | 2019-08-05 |
| K182695 | Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter | Cook Incorporated | 2019-06-17 |
| K182122 | Ureteric Catheters | Coloplast Corp. | 2018-10-04 |
| K180182 | Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter | Cook Incorporated | 2018-09-14 |
| K171043 | Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters | Coloplast Corp. | 2017-12-21 |
| K133750 | OCCLUDER OCCLUSION BALLOON CATHETER | Boston Scientific Corporation | 2014-01-08 |
| K092250 | MEDLINE RED RUBBER URETHRAL CATHETER | Medline Industries, Inc. | 2010-01-21 |
| K083788 | ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR | Endooptiks, Inc. | 2009-03-03 |
| K043581 | DUAL LUMEN CATHETER | Acmi Corporation | 2005-03-03 |
| K030293 | AMSURE RED RUBBER URETHRAL CATHETER | Amsino International, Inc. | 2004-02-04 |
| K033368 | FOSSA URETERAL OPEN LUMEN STENT | Fossa Medical, Inc. | 2003-11-26 |
| K032521 | BARD DUAL LUMEN URETERAL CATHETER | C.R. Bard, Inc. | 2003-11-14 |
| K021856 | PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX | Porges S.A. | 2002-10-17 |
| K020577 | APPLIED URETERAL CATHETER | Applied Medical Resources Corp. | 2002-05-22 |
| K964899 | KENDALL CURITY URETERAL CATHETER | Kendall Healthcare Products Co. Div.Of Tyco Health | 1997-02-07 |
| K962004 | AQ HYDROPHILIC UROLOGICAL CATHETERS | Cook Urological, Inc. | 1996-06-11 |
| K950300 | BARD FLEXIBLE TIP URETERAL CATHETER | C.R. Bard, Inc. | 1995-04-27 |
| K941011 | ACU-SIZER(TM) | Applied Medical Resources | 1994-06-13 |
| K941010 | ACUCISE GUIDEWIRE EXCHANGE SHEATH | Applied Medical Resources | 1994-04-18 |
| K941012 | LOW PRESSURE TAMPONADE BALLOON CATHETER | Applied Medical Resources | 1994-04-18 |
| K933020 | MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER | Boston Scientific Corp | 1994-01-03 |
| K923729 | URETERAL CATHETER | Cook Urological, Inc. | 1993-12-07 |
| K930483 | URETERAL CATHETER | Surgitek | 1993-07-16 |
| K921838 | ACUCISE URETERAL CUTTING CATHETER | Applied Urology, Inc. | 1993-02-26 |
| K914358 | ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP | Hobbs Medical, Inc. | 1991-11-19 |
| K882130 | FOLEY-TEMP(TM) | Mallinckroot, Inc. | 1988-08-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10889942046126 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2024-08-11 |
| 10888277720879 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2022-11-30 |
| 10080196031177 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-12-30 |
| 10080196726219 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-12-30 |
| 10080196726462 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-12-30 |
| 10080196031245 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196031252 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196031276 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196061259 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 08714729191988 | Occluder | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729191995 | Occluder | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729192008 | Occluder | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729161691 | Occluder | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 10801741127059 | Bard® Polyurethane Ureteral Catheters, Cone Tip | C. R. Bard, Inc. | 2016-07-23 |
| 10801741127073 | Bard® Polyurethane Ureteral Catheters, Cone Tip | C. R. Bard, Inc. | 2016-07-23 |
| 10801741127066 | Bard® Polyurethane Ureteral Catheters, Cone Tip | C. R. Bard, Inc. | 2016-07-23 |
| 10801741127035 | Bard® Polyurethane Ureteral Catheters, Spiral Tip | C. R. Bard, Inc. | 2016-07-23 |
| 10801741126984 | Bard® Polyurethane Ureteral Catheters, Whistle Tip | C. R. Bard, Inc. | 2016-07-23 |
| 10801741126977 | Bard® Polyurethane Ureteral Catheters, Whistle Tip | C. R. Bard, Inc. | 2016-07-23 |
| 10801741126960 | Bard® Polyurethane Ureteral Catheters, Whistle Tip | C. R. Bard, Inc. | 2016-07-23 |
| 20607915125947 | ACUCISE® PROCEDURAL PACK STARTER PACK | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915128122 | ACUCISE® PROCEDURAL PACK UNIVERSAL PACK A | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915128139 | ACUCISE® PROCEDURAL PACK UNIVERSAL PACK B | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915128146 | ACUCISE® PROCEDURAL PACK UNIVERSAL PACK C | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915128153 | ACUCISE® PROCEDURAL PACK UNIVERSAL PACK D | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915128160 | ACUCISE® PROCEDURAL PACK | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915128177 | ACUCISE® PROCEDURAL PACK | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915128184 | ACUCISE® PROCEDURAL PACK FEMALE PACK A | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915128191 | ACUCISE® PROCEDURAL PACK FEMALE PACK B | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |
| 20607915128207 | ACUCISE® PROCEDURAL PACK FEMALE PACK C | APPLIED MEDICAL RESOURCES CORPORATION | 2015-10-09 |