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LWH — Counter, Sponge, Surgical Class I

FDA Device Classification

Classification Details

Product Code
LWH
Device Class
Class I
Regulation Number
880.2740
Submission Type
Review Panel
SU
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K121274gauss surgical, incPIXEL APPJune 27, 2012
K120473gauss surgical, incPIXEL APPApril 9, 2012
K100551haldor advanced technologiesORLOCATE SYSTEM MODEL ORL 100August 12, 2010
K093557clearcount medical solutionsSMARTWAND-DTXDecember 18, 2009
K073180clearcount medical solutionsSMARTSPONGE PLUS SYSTEMNovember 19, 2007
K071355clearcount medical solutionsSMARTSPONGE SYSTEMMay 24, 2007
K062642rf surgical systemsRF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100ANovember 2, 2006
K061316medline industriesMEDLINE SURGICAL SPONGE SCANNERNovember 2, 2006
K060076surgicount medicalSURGICOUNT SAFETY-SPONGE SYSTEMMarch 14, 2006
K982260markwell intlMARKWELL GAUZE SPONGEAugust 12, 1998
K972302sage productsPOCKET COUNT OR SAFETCOUNTJuly 25, 1997
K945144michael fischer assocSPONGE COUNTJanuary 12, 1995
K912824devon industriesDEVON SPONGE COUNTER BAGSAugust 26, 1991
K873555gorskGORSK SPONGE CONTAINMENT SYSTEMOctober 23, 1987
K790538devon industriesSPONGE COUNTERApril 4, 1979