Product code FGI

Device name: Catheter, Urethrographic, Male
Medical specialty: Gastroenterology, Urology
Device class: 2
Regulation number: 876.5130
Review panel: GU
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K023019	VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000	Vomed Volzer Medizintechnik GmbH & Co.	2002-12-10
K013360	DFINER UROLOGICAL CATHETER	Neoseed Technology,Llc	2002-02-20
K810370	POLLACK CHAIN CYSOURETHROGRAM SET	Vance Products, Inc.	1981-03-20