FDA.reportPublic FDA data

510(k) K063309

Device
TRU-CABLE
Applicant
Truphatek International, Ltd.
510(k) number
K063309
Product code
FFS
Decision
Substantially Equivalent (SESE)
Decision date
2007-01-12
Date received
2006-11-02
Regulation
876.1500
Classification name
Image, Illumination, Fiberoptic, For Endoscope
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
PAUL DRYDEN
Address
3460 Pt.e Creek Ct. #102 Bonita Springs FL US 34134 34134

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FFS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K072521COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATHCook Urological, Inc.2007-11-20
K061622PS SERIESPhotonic Optische Gerate Gesmbh & Cokg2007-03-05
K061025ACCUTECH ENDOLITE PROBEAccutech Medical Technologies, Inc.2006-05-31
K023633SOVIS OPTIQUE'S ENDOSCOPIC CABLESovis Optique2002-12-31
K001698MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159Cogent Light Technologies, Inc.2000-07-17
K994084SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIESSmith & Nephew, Inc.2000-01-20
K991323SMITH & NEPHEW SUBCUTANEOUS ILLUMINATORSmith & Nephew, Inc.1999-07-06
K983714SOLARTEC SOURCE 270, MODEL # 90123Cogent Light Technologies, Inc.1998-12-23
K982462FIBER OPTIC ENDOILLUMINATION PROBEMicrovision, Inc.1998-09-14
K980636FIBER OPTIC ENDOILLUMINATION PROBEDutch Ophthalmic USA, Inc.1998-05-20
K970217VISTA ILLUMINATION SYSTEMVista Medical Technologies, Inc.1997-04-02
K962595KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONSKARL STORZ Endoscopy-America, Inc.1996-09-04
K950960REDDY ILLUMINATORLuxtec Corp.1995-09-08
K945102MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCEAlm Surgical Equipment, Inc.1994-11-04
K944688LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATORProgressive Dynamics, Inc.1994-11-01