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GAD — Retractor Class I

FDA Device Classification

Classification Details

Product Code
GAD
Device Class
Class I
Regulation Number
878.4800
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K152538j.r. parkerJRP Wound SpreaderApril 13, 2016
K151104spineartOTELO LLJanuary 6, 2016
K132645medtronicTHORATRAK MICS RETRACTOR SYSTEM, RACK, BLADESOctober 4, 2013
K071775ezsurgicalDASHAugust 7, 2007
K050256apple medicalAPPLE MEDICAL/OB MOBIUS ELASTIC RETRACTORApril 26, 2005
K043602medtronic sofamor danekQUADRANT RETRACTOR SYSTEMFebruary 23, 2005
K001339omni-tract surgical, div. minn. scientificMRI FASTSYSTEM RETRACTOR SYSTEMMay 17, 2000
K980588clarus medical systemsCLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000August 18, 1998
K963006scion internationalSCION SAPHENOUS VEIN HARVESTING SYSTEMSeptember 20, 1996
K943875hctVILLALTA RETRACTORNovember 9, 1994
K942002automated medical productsRETRACTORMay 17, 1994
K941448technovationsRETRACTORApril 15, 1994
K930316thomasville medical assocLUNG RETRACTORS: DAVIDSON, SEMBFebruary 10, 1994
K926585t. korossurgical instrumentsTHOROCOSCOPY SELF-RETAINING RETRACTORAugust 6, 1993
K921017medinHARGIS SR2 SELF-RETRACTION SYSTEMJuly 2, 1993
K921020medinHARGIS SELF RETRACTION SYSTEMJuly 2, 1993
K921019medinHARGIS RECTAL SELF RETRATION SYSTEMJuly 2, 1993
K922626andronic devicesADEPT INSTRUMENT POSITIONING ACCESSORYOctober 19, 1992
K922625andronic devicesADEPT ENDOSCOPIC POSITIONEROctober 19, 1992
K920471lifeguard medical productsLEVY ARTICULATING RETRACTORJune 23, 1992