510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023019Substantially Equivalent

Vomed Urethra Olive, Models 1420 000, 1425 000, 1430 000

Vomed Volzer Medizintechnik GmbH & Co., Hot Springs NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K023019 is the FDA 510(k) clearance record for VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000, a class II device, cleared for Vomed Volzer Medizintechnik GmbH & Co. on under FDA product code FGI (Catheter, Urethrographic, Male). FDA records list 3 510(k) clearances for Vomed Volzer Medizintechnik GmbH & Co., from to . As of , FDA records show no recalls naming K023019.

Clearance record

Decision date
Received
(90 days to decision)
Product code
FGI Catheter, Urethrographic, Male
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Vomed Volzer Medizintechnik GmbH & Co. 152b Bridge St., Hot Springs NC
510(k) summary
Statement
Third party review
No

Clearances, product code FGI

Trailing 12 months

FDA records hold no clearances under product code FGI in the trailing twelve months.

FDA records show no clearances under product code FGI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FGI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260