EYB · Catheter, Ureteral, Gastro-Urology
Gastroenterology, Urology · 21 CFR 876.5130 · Class 2
Overview
| Product Code | EYB |
|---|---|
| Device Name | Catheter, Ureteral, Gastro-Urology |
| Regulation | 21 CFR 876.5130 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).
Classification Rationale
(1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Recent Cleared Devices (20 of 28)
Showing 20 most recent of 28 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K192183 | RocaTub Ureteral Catheter | Promepal Sam | Apr 23, 2020 | SESE |
| K191187 | Dornier MINNOW Ureteral Catheter | Dornier Medtech America, Inc. | Sep 18, 2019 | SESE |
| K183323 | UPJ Occlusion Balloon Catheter | Cook Incorporated | Aug 5, 2019 | SESK |
| K182695 | Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter | Cook Incorporated | Jun 17, 2019 | SESK |
| K182122 | Ureteric Catheters | Coloplast Corp. | Oct 4, 2018 | SESE |
| K180182 | Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter | Cook Incorporated | Sep 14, 2018 | SESE |
| K171043 | Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters | Coloplast Corp. | Dec 21, 2017 | SESE |
| K133750 | OCCLUDER OCCLUSION BALLOON CATHETER | Boston Scientific Corporation | Jan 8, 2014 | SESE |
| K092250 | MEDLINE RED RUBBER URETHRAL CATHETER | Medline Industries, Inc. | Jan 21, 2010 | SESE |
| K083788 | ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR | Endooptiks, Inc. | Mar 3, 2009 | SESE |
| K043581 | DUAL LUMEN CATHETER | Acmi Corporation | Mar 3, 2005 | SESE |
| K030293 | AMSURE RED RUBBER URETHRAL CATHETER | Amsino International, Inc. | Feb 4, 2004 | SESE |
| K033368 | FOSSA URETERAL OPEN LUMEN STENT | Fossa Medical, Inc. | Nov 26, 2003 | SESE |
| K032521 | BARD DUAL LUMEN URETERAL CATHETER | C.R. Bard, Inc. | Nov 14, 2003 | SESE |
| K021856 | PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX | Porges S.A. | Oct 17, 2002 | SESE |
| K020577 | APPLIED URETERAL CATHETER | Applied Medical Resources Corp. | May 22, 2002 | SESE |
| K964899 | KENDALL CURITY URETERAL CATHETER | Kendall Healthcare Products Co. Div.Of Tyco Health | Feb 7, 1997 | SESE |
| K962004 | AQ HYDROPHILIC UROLOGICAL CATHETERS | Cook Urological, Inc. | Jun 11, 1996 | SESE |
| K950300 | BARD FLEXIBLE TIP URETERAL CATHETER | C.R. Bard, Inc. | Apr 27, 1995 | SESE |
| K941011 | ACU-SIZER(TM) | Applied Medical Resources | Jun 13, 1994 | SESE |
Top Applicants
- Applied Medical Resources — 3 clearances
- Cook Incorporated — 3 clearances
- C.R. Bard, Inc. — 2 clearances
- Coloplast Corp. — 2 clearances
- Cook Urological, Inc. — 2 clearances
