Atlas FDA

MQR

16 FDA 510(k) clearances · Product code

102 daysmedian time to decision
393 days90th percentile
16clearances measured

FDA profile

Official device name
Stent, Colonic, Metallic, Expandable
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3610
Medical specialty
General, Plastic Surgery
Flags
Implant
Adverse events (MAUDE)
2021: 56 · 2022: 35 · 2023: 38 · 2024: 70 · 2025: 29 · 2026: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System (K234046)Boston Scientific Corporation2024-03-08
WallFlex Colonic Stent System with Anchor Lock Delivery System (K201159)Boston Scientific Corporation2020-08-17
WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System (K200257)Boston Scientific Corporation2020-04-17
HANAROSTENT LowAx Colon/Rectum (NNN) (K190141)M.I.Tech Co., Ltd.2019-03-07
HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) (K183616)M.I.Tech Co., Ltd.2019-01-10
HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) (K180180)M.I.Tech Co., Ltd.2018-11-02
EVOLUTION COLONIC STENT SYSTEM (K113510)Cook Ireland, Ltd.2012-05-17
WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM (K061877)Boston Scientific Corp2006-09-15
ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 (K060323)Boston Scientific Corporation2006-05-12
WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM (K042065)Boston Scientific Corp2004-09-30
ULTRAFLEX PRECISION COLONIC STENT (K030769)Boston Scientific Corp2003-07-14
WALLSTENT ENTERNAL PROSTHESIS (K000281)Boston Scientific Corp2000-05-12
WILSON-COOK COLONIC Z-STENT (K990034)Med Institute, Inc.2000-04-17
MEMOTHERM COLORECTAL STENT (K990504)C.R. Bard, Inc.2000-03-16
WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM (K991056)Boston Scientific Corp1999-06-22
WALLSTENT ENTERAL ENDOPROTHESIS (K954290)Boston Scientific Scimed, Inc.1996-07-10

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Every clearance here is in the API, with alerts when new ones post.