EYB — Catheter, Ureteral, Gastro-Urology Class II
FDA Device Classification
Classification Details
- Product Code
- EYB
- Device Class
- Class II
- Regulation Number
- 876.5130
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K192183 | promepal sam | RocaTub Ureteral Catheter | April 23, 2020 |
| K191187 | dornier medtech america | Dornier MINNOW Ureteral Catheter | September 18, 2019 |
| K183323 | cook incorporated | UPJ Occlusion Balloon Catheter | August 5, 2019 |
| K182695 | cook incorporated | Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter | June 17, 2019 |
| K182122 | coloplast | Ureteric Catheters | October 4, 2018 |
| K180182 | cook incorporated | Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Cathet | September 14, 2018 |
| K171043 | coloplast | Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric C | December 21, 2017 |
| K133750 | boston scientific corporation | OCCLUDER OCCLUSION BALLOON CATHETER | January 8, 2014 |
| K092250 | medline industries | MEDLINE RED RUBBER URETHRAL CATHETER | January 21, 2010 |
| K083788 | endooptiks | ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR | March 3, 2009 |
| K043581 | acmi corporation | DUAL LUMEN CATHETER | March 3, 2005 |
| K030293 | amsino international | AMSURE RED RUBBER URETHRAL CATHETER | February 4, 2004 |
| K033368 | fossa medical | FOSSA URETERAL OPEN LUMEN STENT | November 26, 2003 |
| K032521 | c.r. bard | BARD DUAL LUMEN URETERAL CATHETER | November 14, 2003 |
| K021856 | porges | PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, | October 17, 2002 |
| K020577 | applied medical resources | APPLIED URETERAL CATHETER | May 22, 2002 |
| K964899 | kendall healthcare products co. div.of tyco health | KENDALL CURITY URETERAL CATHETER | February 7, 1997 |
| K962004 | cook urological | AQ HYDROPHILIC UROLOGICAL CATHETERS | June 11, 1996 |
| K950300 | c.r. bard | BARD FLEXIBLE TIP URETERAL CATHETER | April 27, 1995 |
| K941011 | applied medical resources | ACU-SIZER(TM) | June 13, 1994 |