Catheter, Urethrographic, Male
The Male Urethrographic Catheter is a single-use catheter designed for retrograde urethrography in male patients, used to introduce contrast medium for radiological examination of the urethra. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party 510(k) review. The product code is FGI, regulated under 21 CFR 876.5130, within the Gastroenterology, Urology specialty.
Basic Information
- Product Code
- FGI
- Device Class
- FDA class 2
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K023019 | VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000 | Dec 10, 2002 | Substantially Equivalent | VOMED VOLZER MEDIZINTECHNIK GMBH & CO. |
| K013360 | DFINER UROLOGICAL CATHETER | Feb 20, 2002 | Substantially Equivalent | NEOSEED TECHNOLOGY,LLC |
| K810370 | POLLACK CHAIN CYSOURETHROGRAM SET | Mar 20, 1981 | Substantially Equivalent | VANCE PRODUCTS, INC. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.