# K023019: Vomed Urethra Olive, Models 1420 000, 1425 000, 1430 000

- Pathway: 510(k) (Traditional)
- Applicant: Vomed Volzer Medizintechnik GmbH & Co.
- Decided: Dec 10, 2002 after 90 days
- Product code: FGI (Catheter, Urethrographic, Male)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
VOMED urethra olives are acorn-tipped reusable devices designed for use in ureterography. With the aid of a ureterocystoscope, a radiopaque medium is injected into the ureter for radiologic imaging. The VOMED urethra olives are accessories of male urethrographic catheters. They are placed temporarily on the external end of the penis to guide the insertion of the catheters and to facilitate the injection of the opaque substance. The devices are indicated for diagnostic and therapeutic urologic procedures.

Source page: https://510kreport.com/device/K023019
Methodology: https://510kreport.com/methodology