KNY · Accessories, Catheter, G-U
Gastroenterology, Urology · 21 CFR 876.5130 · Class 2
Overview
| Product Code | KNY |
|---|---|
| Device Name | Accessories, Catheter, G-U |
| 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 64)
Showing 20 most recent of 64 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K182144 | Bi-Flex Evo | Promepla Sam | Sep 7, 2018 | SESE |
| K162356 | Vesair Cystoscopic Sheath | Solace Therapeutics | Mar 2, 2017 | SESE |
| K140441 | BI-FLEX URETERAL ACCESS SHEATH | Promepla Sam | Jun 17, 2014 | SESE |
| K140562 | WIJAY EZ-VOID EXTERNAL CATHETER VALVE | Leomed, LLC | Jun 16, 2014 | SESE |
| K141252 | GUARDIAN URETHRAL SHEATH | Solace Therapeutics | Jun 9, 2014 | SESE |
| K131803 | GUARDIAN URETHRAL SHEATH | Solace Therapeutics | Aug 20, 2013 | SESE |
| K123170 | VARI-PASS VARIABLE LENGTH ACCESS SHEATH | Olympus Surgical Technologies America | Feb 4, 2013 | SESE |
| K120160 | ROCAMED ROCAUS PLATINUM | Promepla Sam | May 14, 2012 | SESE |
| K112209 | PREFILLED CATHETER INFLATION SYRINGE | Avail Medical Products, Inc. | Sep 8, 2011 | SESE |
| K090121 | PRE-FILLED CATHETER INFLATION SYRINGE | Avail Medical Products, Inc. | Apr 15, 2009 | SESE |
| K052298 | CYSTOGLIDE INTRODUCER SHEATH | Percutaneous Systems, Incorporated | Dec 12, 2006 | SESE |
| K062240 | CAREVENT | Chief Medical, LLC | Oct 16, 2006 | SESE |
| K052952 | CATHASSIST | Physician Technologies, Inc. | May 14, 2006 | SESE |
| K052134 | CYSTOGLIDE DILATING INTRODUCER SHEATH | Percutaneous Systems, Inc. | Sep 22, 2005 | SESE |
| K051593 | UROPASS URETERAL ACCESS SHEATH, MODEL 61224 | Acmi Corporation | Sep 2, 2005 | SESE |
| K042531 | UPDATED SLIP UROLOGY INTRODUCER SHEATH | Percutaneous Systems, Incorporated | Feb 1, 2005 | SESE |
| K042877 | MICROVERTER URETERAL ACCESS SHEATH | Percutaneous Systems, Inc. | Nov 16, 2004 | SESE |
| K040520 | SLIP UROLOGY INTRODUCER SHEATH | Percutaneous Systems, Inc. | May 20, 2004 | SESE |
| K032127 | HEMEDEX FIXATION DEVICE | Hemedex Incorporated | Dec 30, 2003 | SESE |
| K023690 | CATHETER CONNECTOR | World Metals, Inc. | Feb 28, 2003 | SESE |
Top Applicants
- Lake Region Mfg., Inc. — 3 clearances
- Percutaneous Systems, Inc. — 3 clearances
- Promepla Sam — 3 clearances
- Solace Therapeutics — 3 clearances
- Avail Medical Products, Inc. — 2 clearances
