Medical Device Manufacturer · US , Marlborough , MA

Boston Scientific Corporation - FDA 510(k) Cleared Devices

228 submissions · 215 cleared · Since 2005
228
Total
215
Cleared
1
Denied
97 devices
76-97 of 97
Cleared Jan 24, 2014
CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES
K133987 · FDI
Gastroenterology & Urology · 29d
Cleared Jan 08, 2014
OCCLUDER OCCLUSION BALLOON CATHETER
K133750 · EYB
Gastroenterology & Urology · 30d
Cleared Jan 03, 2014
EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K133312 · ODG
Gastroenterology & Urology · 67d
Cleared Dec 06, 2013
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K130004 · ESW
Gastroenterology & Urology · 338d
Cleared May 22, 2013
UROMAX ULTRA BALLOON DILATATION CATHETER
K130804 · EZN
Gastroenterology & Urology · 58d
Cleared Dec 03, 2012
RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611,...
K122660 · PKL
Gastroenterology & Urology · 94d
Cleared Sep 28, 2012
WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY...
K122072 · FGE
Gastroenterology & Urology · 74d
Cleared May 02, 2012
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K120983 · ESW
Gastroenterology & Urology · 30d
Cleared Feb 10, 2012
CRE DITATATION BALLON
K112994 · FGE
Gastroenterology & Urology · 126d
Cleared Dec 29, 2011
WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY...
K112543 · FGE
Gastroenterology & Urology · 119d
Cleared Sep 14, 2011
EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K112198 · ODG
Gastroenterology & Urology · 44d
Cleared Apr 20, 2011
CRE BALLOON DILATATION CATHETER
K110833 · FDT
Gastroenterology & Urology · 26d
Cleared Apr 14, 2011
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
K110887 · KNS
Gastroenterology & Urology · 15d
Cleared Dec 22, 2010
RESOLUTION II CLIP
K102764 · PKL
Gastroenterology & Urology · 89d
Cleared Nov 05, 2010
IMAGER II UROLOGY TORQUE CATHETER (C1 TIP)
K102527 · KOD
Gastroenterology & Urology · 64d
Cleared Mar 30, 2010
RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K100712 · FCG
Gastroenterology & Urology · 18d
Cleared Jul 01, 2009
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K091816 · ESW
Gastroenterology & Urology · 13d
Cleared Jun 26, 2009
WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710,...
K091510 · ESW
Gastroenterology & Urology · 35d
Cleared Apr 07, 2009
WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510,...
K083627 · FGE
Gastroenterology & Urology · 120d
Cleared Sep 05, 2008
POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280,...
K080332 · ESW
Gastroenterology & Urology · 211d
Cleared Dec 14, 2007
THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
K072476 · KNT
Gastroenterology & Urology · 101d
Cleared May 12, 2006
ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380
K060323 · MQR
Gastroenterology & Urology · 92d

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