FDA 510(k) Applications for Medical Device Product Code "LWH"
(Counter, Sponge, Surgical)

FDA 510(k) Number Applicant Device Name Decision Date
K093557 CLEARCOUNT MEDICAL SOLUTIONS SMARTWAND-DTX 12/18/2009
K073180 CLEARCOUNT MEDICAL SOLUTIONS, INC. SMARTSPONGE PLUS SYSTEM 11/19/2007
K071355 CLEARCOUNT MEDICAL SOLUTIONS, INC. SMARTSPONGE SYSTEM 05/24/2007
K121274 GAUSS SURGICAL, INC. PIXEL APP 06/27/2012
K120473 GAUSS SURGICAL, INC. PIXEL APP 04/09/2012
K100551 HALDOR ADVANCED TECHNOLOGIES LTD ORLOCATE SYSTEM MODEL ORL 100 08/12/2010
K982260 MARKWELL INTL., INC. MARKWELL GAUZE SPONGE 08/12/1998
K061316 MEDLINE INDUSTRIES, INC. MEDLINE SURGICAL SPONGE SCANNER 11/02/2006
K062642 RF SURGICAL SYSTEMS, INC. RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A 11/02/2006
K972302 SAGE PRODUCTS, INC. POCKET COUNT OR SAFETCOUNT 07/25/1997
K060076 SURGICOUNT MEDICAL SURGICOUNT SAFETY-SPONGE SYSTEM 03/14/2006


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