Product code EZO

Device name: Urethrotome
Medical specialty: Gastroenterology, Urology
Device class: 2
Regulation number: 876.4770
Review panel: GU
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K000905	URETHROTOME 8667.XXX AND 8670.XXX	Richard Wolf Medical Instruments Corp.	2000-05-12
K950719	OES UROLOGY	Olympus America, Inc.	1996-12-11
K945686	KARL STORZ KNIVES, CURETTES	KARL STORZ Endoscopy-America, Inc.	1995-02-13
K934730	KARL STORZ ENDOSCOPIC COLD KNIFE BLADES	KARL STORZ Endoscopy-America, Inc.	1994-01-11
K904939	FLEXIBLE AND RIGID URETEROTOME SYSTEM	Olympus Corp.	1992-01-07

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
04048551232781	n.a.	Karl Storz GmbH & Co. KG	2025-08-11
04048551232378	n.a.	Karl Storz GmbH & Co. KG	2025-08-11
04046826063047	Medicon	Medicon eG. Chirurgiemechaniker-Genossenschaft	2018-11-13
04046826063030	Medicon	Medicon eG. Chirurgiemechaniker-Genossenschaft	2018-11-13
04046826063023	Medicon	Medicon eG. Chirurgiemechaniker-Genossenschaft	2018-11-13
04048551233986	n.a.	Karl Storz GmbH & Co. KG	2018-09-04
10649111188558	Sklar®	SKLAR CORPORATION	2017-06-23
10801334005641	Greenwald Surgical Company, Inc.	GRACE MANUFACTURING, INC.	2016-09-23
04048551080627	n.a.	Karl Storz GmbH & Co. KG	2016-09-23
10801334005634	Greenwald Surgical Company, Inc.	GRACE MANUFACTURING, INC.	2016-09-23
10801334005627	Greenwald Surgical Company, Inc.	GRACE MANUFACTURING, INC.	2016-09-23
10801334005610	Greenwald Surgical Company, Inc.	GRACE MANUFACTURING, INC.	2016-09-23
10801334005597	Greenwald Surgical Company, Inc.	GRACE MANUFACTURING, INC.	2016-09-23
10801334000950	Greenwald Surgical Company, Inc.	GRACE MANUFACTURING, INC.	2016-09-23
10801334000967	Greenwald Surgical Company, Inc.	GRACE MANUFACTURING, INC.	2016-09-23
10801334001261	Greenwald Surgical Company, Inc.	GRACE MANUFACTURING, INC.	2016-09-23
10801334005528	Greenwald Surgical Company, Inc.	GRACE MANUFACTURING, INC.	2016-09-23
10801334005542	Greenwald Surgical Company, Inc.	GRACE MANUFACTURING, INC.	2016-09-23
10801334005559	Greenwald Surgical Company, Inc.	GRACE MANUFACTURING, INC.	2016-09-23
10801334005566	Greenwald Surgical Company, Inc.	GRACE MANUFACTURING, INC.	2016-09-23
10801334005573	Greenwald Surgical Company, Inc.	GRACE MANUFACTURING, INC.	2016-09-23
10801334005580	Greenwald Surgical Company, Inc.	GRACE MANUFACTURING, INC.	2016-09-23
10801334005603	Greenwald Surgical Company, Inc.	GRACE MANUFACTURING, INC.	2016-09-23
04042761051910	Olympus	OLYMPUS Winter & Ibe GmbH	2016-09-22
04042761005340	Olympus	OLYMPUS Winter & Ibe GmbH	2016-09-22
04042761000024	Olympus	OLYMPUS Winter & Ibe GmbH	2016-09-22
04042761006361	Olympus	OLYMPUS Winter & Ibe GmbH	2016-09-21
04042761021661	Olympus	OLYMPUS Winter & Ibe GmbH	2016-09-21
04042761006354	Olympus	OLYMPUS Winter & Ibe GmbH	2016-09-21
04042761005258	Olympus	OLYMPUS Winter & Ibe GmbH	2016-09-21

Product code EZO

Related 510(k) Records#

Related GUDID Devices#