FDA Product Code
FDA Product Code EYB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5130
510(k) Clearances — 28 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K192183 | RocaTub Ureteral Catheter | Promepal Sam | 2020-04-23 | Traditional | PDF ↗ |
| K191187 | Dornier MINNOW Ureteral Catheter | Dornier Medtech America, Inc. | 2019-09-18 | Traditional | PDF ↗ |
| K183323 | UPJ Occlusion Balloon Catheter | Cook Incorporated | 2019-08-05 | Traditional | PDF ↗ |
| K182695 | Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter | Cook Incorporated | 2019-06-17 | Traditional | PDF ↗ |
| K182122 | Ureteric Catheters | Coloplast Corp. | 2018-10-04 | Traditional | PDF ↗ |
| K180182 | Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter | Cook Incorporated | 2018-09-14 | Traditional | PDF ↗ |
| K171043 | Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters | Coloplast Corp. | 2017-12-21 | Traditional | PDF ↗ |
| K133750 | OCCLUDER OCCLUSION BALLOON CATHETER | Boston Scientific Corporation | 2014-01-08 | Traditional | PDF ↗ |
| K092250 | MEDLINE RED RUBBER URETHRAL CATHETER | Medline Industries, Inc. | 2010-01-21 | Traditional | PDF ↗ |
| K083788 | ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR | Endooptiks, Inc. | 2009-03-03 | Traditional | PDF ↗ |
| K043581 | DUAL LUMEN CATHETER | Acmi Corporation | 2005-03-03 | Special | PDF ↗ |
| K030293 | AMSURE RED RUBBER URETHRAL CATHETER | Amsino International, Inc. | 2004-02-04 | Traditional | PDF ↗ |
| K033368 | FOSSA URETERAL OPEN LUMEN STENT | Fossa Medical, Inc. | 2003-11-26 | Special | PDF ↗ |
| K032521 | BARD DUAL LUMEN URETERAL CATHETER | C.R. Bard, Inc. | 2003-11-14 | Traditional | PDF ↗ |
| K021856 | PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX | Porges S.A. | 2002-10-17 | Traditional | PDF ↗ |
| K020577 | APPLIED URETERAL CATHETER | Applied Medical Resources Corp. | 2002-05-22 | Traditional | PDF ↗ |
| K964899 | KENDALL CURITY URETERAL CATHETER | Kendall Healthcare Products Co. Div.Of Tyco Health | 1997-02-07 | Traditional | PDF ↗ |
| K962004 | AQ HYDROPHILIC UROLOGICAL CATHETERS | Cook Urological, Inc. | 1996-06-11 | Traditional | PDF ↗ |
| K950300 | BARD FLEXIBLE TIP URETERAL CATHETER | C.R. Bard, Inc. | 1995-04-27 | Traditional | PDF ↗ |
| K941011 | ACU-SIZER(TM) | Applied Medical Resources | 1994-06-13 | Traditional | PDF ↗ |
| K941010 | ACUCISE GUIDEWIRE EXCHANGE SHEATH | Applied Medical Resources | 1994-04-18 | Traditional | PDF ↗ |
| K941012 | LOW PRESSURE TAMPONADE BALLOON CATHETER | Applied Medical Resources | 1994-04-18 | Traditional | PDF ↗ |
| K933020 | MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER | Boston Scientific Corp | 1994-01-03 | Traditional | PDF ↗ |
| K923729 | URETERAL CATHETER | Cook Urological, Inc. | 1993-12-07 | Traditional | PDF ↗ |
| K930483 | URETERAL CATHETER | Surgitek | 1993-07-16 | Traditional | PDF ↗ |
| K921838 | ACUCISE URETERAL CUTTING CATHETER | Applied Urology, Inc. | 1993-02-26 | Traditional | PDF ↗ |
| K914358 | ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP | Hobbs Medical, Inc. | 1991-11-19 | Traditional | PDF ↗ |
| K882130 | FOLEY-TEMP(TM) | Mallinckroot, Inc. | 1988-08-09 | Traditional | PDF ↗ |
Product code EYB · Class II · Gastroenterology, Urology. Data: openFDA.