Atlas FDA

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

FDA 510(k) clearance K234046 · decided 2024-03-08

Clearance details

K-number
K234046
Device name
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
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2023-12-21
Decision date
2024-03-08
Days to decision
78 days
Clearance type
Special
Product code
MQR
Device class
2
Regulation number
878.3610
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Marborough, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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

Recalls involving this device

No recalls on record reference this clearance.

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