Atlas FDA

WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System

FDA 510(k) clearance K200257 · decided 2020-04-17

Clearance details

K-number
K200257
Device name
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
2020-02-03
Decision date
2020-04-17
Days to decision
74 days
Clearance type
Traditional
Product code
MQR
Device class
2
Regulation number
878.3610
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Marlboro, 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; 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
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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