MJC · Catheter, Urological (Antimicrobial) And Accessories
Gastroenterology, Urology · 21 CFR 876.5130 · Class 2
Overview
| Product Code | MJC |
|---|---|
| Device Name | Catheter, Urological (Antimicrobial) And Accessories |
| 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 (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233094 | Wellead® Latex Foley Catheter | Well Lead Medical (Hainan) Co., Ltd. | Jun 6, 2024 | SESE |
| K040658 | BARDEX I.C. LATEX FOLEY CATHETER | C.R. Bard, Inc. | Sep 29, 2004 | SESE |
| K033477 | HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT | Rochester Medical Corp. | Jun 10, 2004 | SESE |
| K000251 | SPECTRUM SILICONE FOLEY CATHETER | Cook Urological, Inc. | Aug 30, 2000 | SESE |
| K001143 | RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER | Rochester Medical Corp. | Jul 7, 2000 | SESE |
| K993464 | BARDEX I.C. PEDIATRIC FOLEY CATHETER | C.R. Bard, Inc. | Dec 10, 1999 | SESE |
| K984136 | BARDEX LUBRI-SIL I.C. FOLEY CATHETER | Bard Medical Div. | Feb 16, 1999 | SESE |
| K983101 | BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 | C.R. Bard, Inc. | Nov 3, 1998 | SESE |
| K971627 | SILICONE ANTIBACTERIAL FOLEY CATHETER | Rochester Medical Corp. | Jan 13, 1998 | SESE |
| K910318 | BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER | C.R. Bard, Inc. | Aug 18, 1994 | SESE |
Top Applicants
- C.R. Bard, Inc. — 4 clearances
- Rochester Medical Corp. — 3 clearances
- Bard Medical Div. — 1 clearance
- Cook Urological, Inc. — 1 clearance
- Well Lead Medical (Hainan) Co., Ltd. — 1 clearance
