LJH · System, Irrigation, Urological
Gastroenterology, Urology · 21 CFR 876.5130 · Class 2
Overview
| Product Code | LJH |
|---|---|
| Device Name | System, Irrigation, Urological |
| 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 |
|---|---|---|---|---|
| K162992 | Karl Storz UROMAT E.A.S.I. | Karl Storz Endoscopy America, Inc. | Jul 7, 2017 | SESE |
| K070873 | AMSURE BLADDER IRRIGATION SET | Amsino Intl., Inc. | Dec 19, 2007 | SESE |
| K071832 | MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM | Medical Scientific, Inc. | Sep 18, 2007 | SESE |
| K063700 | SPYGLASS IRRIGATION SYSTEM | Medical Scientific, Inc. | Feb 8, 2007 | SESE |
| K062551 | NEXUS IRRIGATION TUBING SET | Nexus Medical, LLC | Dec 15, 2006 | SESE |
| K042457 | URO PRO | W.O.M. World of Medicine AG | Oct 25, 2004 | SESE |
| K040094 | PIGGYBACK IRRIGATING SYSTEM | Kosin Technologies, LLC | Apr 15, 2004 | SESE |
| K023808 | IRRIGATION SETS | International Medsurg Connection | Mar 10, 2003 | SESE |
| K010607 | MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 | Benlan, Inc. | Nov 28, 2001 | SESE |
| K010122 | CONTINUOUS FLOW Y-TUBING | G.U.-Tek | Jun 4, 2001 | SESE |
| K001325 | FLO ASSISTANT, MODEL 4-250-00 | Northgate Technologies, Inc. | Aug 18, 2000 | SESE |
| K990909 | MTP UROPUMP DISPOSABLE TUBING SET | Mtp Medical Technical Promotion GmbH | Jun 9, 1999 | SESE |
| K981615 | KSEA UROPUMP | KARL STORZ Endoscopy-America, Inc. | Jul 8, 1998 | SESE |
| K980808 | ENDO FMS UROLOGY | Future Medical Systems, Inc. | May 8, 1998 | SESE |
| K971982 | KARL STORZ MODEL 203020 20 EQUIMAT | KARL STORZ Endoscopy-America, Inc. | Aug 12, 1997 | SESE |
| K970946 | MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET | Medline Industries, Inc. | Jun 10, 1997 | SESE |
| K962670 | NHMC IRRIGATION TRAY | National Healthcare Mfg. Corp. | Aug 14, 1996 | SESE |
| K960787 | TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS | Baxter Healthcare Corp | May 14, 1996 | SESE |
| K943361 | NORTHGATE FLOW ASSIST TUBING FOR UROLOGY | Northgate Technologies, Inc. | Sep 29, 1995 | SESE |
| K952583 | AQUISEN | Aquintel, Inc. | Aug 24, 1995 | SESE |
Top Applicants
- KARL STORZ Endoscopy-America, Inc. — 4 clearances
- Medical Scientific, Inc. — 2 clearances
- Northgate Technologies, Inc. — 2 clearances
- American Cystocope Makers, Inc. — 1 clearance
- Amsino Intl., Inc. — 1 clearance
