FDA.reportPublic FDA data

510(k) K934531

Device
Auto Suture Disposable Light Cable
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
510(k) number
K934531
Product code
FCW
Decision
Substantially Equivalent (SESE)
Decision date
1994-05-18
Date received
1993-09-20
Regulation
876.1500
Classification name
Light Source, Fiberoptic, Routine
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
PAUL D SMOLENSKI
Address
150 Glover Ave. Norwalk CT US 06856 06856

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FCW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K131226NOVAPROBE LED LIGHT SOURCENovaprobe Incorporated2014-07-24
K123956POWER LED 175KARL STORZ Endoscopy-America, Inc.2013-01-25
K123359OVS1 VIDEO SYSTEMOlive Medical Corp.2012-12-19
K121724ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2Richard Wolf Medical Instruments Corp.2012-09-20
K093792LED LIGHT SOURCESunoptic Technologies, LLC2010-03-18
K091968KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020CKARL STORZ Endoscopy-America, Inc.2009-09-14
K082813STRYKER LED LIGHTSOURCEStryker Corp.2008-12-19
K081477LUXTEC MLX LIGHT SOURCEIntegra Luxtec, Inc.2008-06-18
K032430ACUEITY MEDICAL LIGHT SOURCEAcueity, Inc.2003-09-05
K012265METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088Circon Video2001-10-17
K000229VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCEVideolabs, Inc.2000-03-21
K993300COLDLIGHTSOURCE PL3000Fiber Imaging Technologies, Inc.1999-11-05
K99244750 W METAL HALIDE ILLUMINATOR, VES 0501.Angiolaz, Inc.1999-10-20
K970598INTEGRATED VISUALIZATION SYSTEMUrohealth, Inc.1997-03-12
K964586PRESCOTT'S LIGHT SOURCE MODEL NO. II-150Iba/Griffith1997-01-17