FGI · Catheter, Urethrographic, Male
Gastroenterology, Urology · 21 CFR 876.5130 · Class 2
Overview
| Product Code | FGI |
|---|---|
| Device Name | Catheter, Urethrographic, Male |
| 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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K023019 | VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000 | Vomed Volzer Medizintechnik GmbH & Co. | Dec 10, 2002 | SESE |
| K013360 | DFINER UROLOGICAL CATHETER | Neoseed Technology,Llc | Feb 20, 2002 | SESE |
| K810370 | POLLACK CHAIN CYSOURETHROGRAM SET | Vance Products, Inc. | Mar 20, 1981 | SESE |
Top Applicants
- Neoseed Technology,Llc — 1 clearance
- Vance Products, Inc. — 1 clearance
- Vomed Volzer Medizintechnik GmbH & Co. — 1 clearance
