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
26-50 of 97
Cleared Dec 20, 2021
AdVance XP Male Sling System
K211847 · OTM
Gastroenterology & Urology · 188d
Cleared Nov 22, 2021
Agile Esophageal OTW Stent System
K211960 · ESW
Gastroenterology & Urology · 151d
Cleared Jul 21, 2021
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
K211223 · OTN
Gastroenterology & Urology · 89d
Cleared May 26, 2021
SpyGlass Discover Retrieval Basket
K203322 · LQR
Gastroenterology & Urology · 195d
Cleared May 06, 2021
AutoCap RX
K210353 · ODC
Gastroenterology & Urology · 87d
Cleared Apr 27, 2021
Safety Trocar Cannula
K211072 · KNT
Gastroenterology & Urology · 15d
Cleared Apr 26, 2021
Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit,...
K200260 · FAD
Gastroenterology & Urology · 448d
Cleared Apr 15, 2021
AXIOS Stent and Electrocautery Enhanced Delivery System
K203132 · PCU
Gastroenterology & Urology · 178d
Cleared Dec 18, 2020
Advanix Biliary Stent with NaviFlex RX Delivery System
K203162 · FGE
Gastroenterology & Urology · 56d
Cleared Dec 03, 2020
ORISE ProKnife
K200404 · KNS
Gastroenterology & Urology · 288d
Cleared Oct 08, 2020
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy...
K202478 · FDI
Gastroenterology & Urology · 41d
Cleared Sep 01, 2020
Resolution 360™ ULTRA Clip
K193424 · PKL
Gastroenterology & Urology · 266d
Cleared Aug 17, 2020
WallFlex Colonic Stent System with Anchor Lock Delivery System
K201159 · MQR
Gastroenterology & Urology · 109d
Cleared Apr 17, 2020
WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex...
K200257 · MQR
Gastroenterology & Urology · 74d
Cleared Jan 02, 2020
Ureteral Stent Systems, Biliary Drainage Catheters
K191446 · FAD
Gastroenterology & Urology · 216d
Cleared Dec 13, 2019
EXALT Model D Single-Use Duodenoscope, EXALT Controller
K193202 · FDT
Gastroenterology & Urology · 23d
Cleared Aug 26, 2019
AXIOS Stent and Electrocautery Enhanced Delivery System
K192043 · PCU
Gastroenterology & Urology · 26d
Cleared Aug 16, 2019
Tria Soft Ureteral Stent
K191609 · FAD
Gastroenterology & Urology · 60d
Cleared Jul 25, 2019
Stonetome Stone Removal Device
K191789 · LQR
Gastroenterology & Urology · 22d
Cleared May 24, 2019
Tria Firm Ureteral Stent
K190603 · FAD
Gastroenterology & Urology · 77d
Cleared Apr 16, 2019
Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm...
K183619 · FAE
Gastroenterology & Urology · 111d
Cleared Mar 25, 2019
AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced...
K181905 · PCU
Gastroenterology & Urology · 252d
Cleared Jan 22, 2019
SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery...
K183636 · FBN
Gastroenterology & Urology · 27d
Cleared Nov 27, 2018
AdVance XP Male Sling
K182169 · OTM
Gastroenterology & Urology · 109d
Cleared Sep 21, 2018
Agile Esophageal Stent System
K180144 · ESW
Gastroenterology & Urology · 246d

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