EYB — Catheter, Ureteral, Gastro-Urology Class II
FDA product code EYB covers "Catheter, Ureteral, Gastro-Urology", a Class II medical device regulated under 21 CFR 876.5130. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |