510(k) · Cleared
ClearedVomed Urethra Olive, Models 1420 000, 1425 000, 1430 000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vomed Volzer Medizintechnik GmbH & Co. · FGI Catheter, Urethrographic, Male
Cleared on Dec 10, 2002 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 10, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- FGI
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FGI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All FGI devicesFGI Catheter, Urethrographic, Male: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FGI
FDA has decided no FGI device since 2007.
Median 510(k) review, days · FGI
Too few FGI 510(k)s in any year since 2007 to give a median.
Recalls per year · FGI
No recall names FGI since 2007.
Adverse event reports per year · FGI
No MAUDE report names FGI since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023019: Vomed Urethra Olive, Models 1420 000, 1425 000, 1430 000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023019
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026