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510(k) K931546

Device
END-IRRIGATING ENDOILLUMINATOR
Applicant
INFINITECH, INC.
510(k) number
K931546
Product code
FST  
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-09
Date received
1993-03-29
Regulation
878.4580
Classification name
Light, Surgical, Fiberoptic
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ALAN T BECKMAN
Address
750 Goddard Ave. Chesterfield MO US 63005 63005

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FST  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K200874TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal EndInnovasis, Inc.2020-06-30
K141330ENDO-CORDEnroxtech, Inc.2014-12-15
K122637LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999Stryker Spine2012-11-01
K113697EIGR SURGICAL ILLUMINATION SYSTEMInvuity, Inc.2012-02-10
K113330CABLECAPSensormed2012-01-12
K102266ISOLED AC-POWERED LED HEADLIGHT SYSTEMIsolux, LLC2010-09-24
K101496CABLECAP MODEL: WLF, STZ, ACMSensormed2010-09-14
K10038821ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMSMedical Illumination International, Inc.2010-06-22
K100395HARMONY VLED SURGICAL LIGHTNING SYSTEMSTERIS Corporation2010-03-17
K093386CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FSTBfw, Inc.2010-01-28
K090070INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEMInvuity, Inc.2009-04-22
K083710RETRACTOR LITEThomas Surgical Instruments, Inc.2009-02-23
K082992AXXION LIGHT GUIDESpinal Elements, Inc.2009-02-18
K080962LITE WAND IIThompson Surgical Instruments, Inc.2008-06-25
K080367ZIMMER MIS LIGHTZimmer Spine, Inc.2008-02-22

Legacy Summary#

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FDA Review#

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