510(k) K923436

Device: ILLUMINATED URETERAL CATHETER
Applicant: COOK UROLOGICAL, INC.
510(k) number: K923436
Product code: FCS
Decision: Substantially Equivalent (SESE)
Decision date: 1993-03-05
Date received: 1992-07-13
Regulation: 876.4020
Classification name: Light, Catheter, Fiberoptic, Glass, Ureteral
Medical specialty: Gastroenterology/Urology
Review panel: Gastroenterology/Urology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: TAMMY BACON
Address: 1100 W. Morgan St. P.O. Box 227 Spencer IN US 47460 47460

FDA Registration Numbers#

3002807314
3015532525
3010155661
3010707607
3008837339
1820334
3008328690
9610617
3014342096
3008132398
2936485
3010202439
3007303113

Source Documents#

Other 510(k) Records For Product Code FCS #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K151243	STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]	Stryker Endoscopy	2015-08-20
K061548	STRYKER URETERAL ILLUMINATION SYSTEM IV	Stryker Corp.	2006-09-28
K982542	STRYKER URETERAL ILLUMINATOR SYSTEM III	Stryker Endoscopy	1998-09-22
K943801	URIGLOW TRANSILLUMINATING URETERIC STENT MODEL	Rocket of London, Ltd.	1995-08-15
K945088	GABRIEL URETERAL ILLUMINATOR SYSTEM II	Gabriel Medical, Inc.	1995-02-07
K941506	URETERAL ILLUMINATOR	Apple Medical Corp.	1994-10-05
K940019	GABRIEL URETERAL ILLUMINATOR SYSTEM	Gabriel Medical, Inc.	1994-05-02
K874680	LASEGUIDE 600A, 600B, 400A, AND 400B	Laser Peripherals, LLC	1988-03-23
K880071	SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE	Laserguide	1988-03-22

Legacy Summary#

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