510(k) K242950

Device: WallFlex Biliary PLUS RX Stent System
Applicant: Boston Scientific
510(k) number: K242950
Product code: FGE
Decision: Unknown (SESU)
Decision date: 2024-12-06
Date received: 2024-09-23
Regulation: 876.5010
Classification name: Stents, Drains And Dilators For The Biliary Ducts
Medical specialty: Gastroenterology, Urology
Review panel: Gastroenterology, Urology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Alexis Erazo
Address: 100 Boston Scientific Way Marlboro MA US 01752 01752

FDA Registration Numbers

1450395
3014769442
1061124
3004129994
3002504068
3014328942
3035451914
3006131984
2183870
2183744
1222168
3012536737
3006260740
2032098
1644312
2134265
3001845648
3003910212
3011347300
3030447506
3011050570
3013557562
9616099
2024168
2246552
9616684
1225687
3031276312
1721676
1820334
2939561
3033589330
3006950086
1317547
3005099803
3013162291
3005089785
2126666
2024024
3002807314
1018233
1417485
9710284
1223925
3021009035
1828132
3030733800
1037905
1531050
3013337852
1625425
3008146331
3013152301
3014279513
3040505963
3010155661
9680809
1058584
3011146996
3008040402
3009526575
3014579161
3007695959
1928237
1000393132
3012480535
1724474
1319639
3004091615
3011458193
9681477
3009763019
3021632375
9614641
3008492676
3013460719
2030624
3009018440
3030446844
3027260597
3005941719
3013440400
3005580113
1000523114
3010273872
1123137
3009121749
1220477
2020394
3011642792
1643817
3003898360
8010047
2027111
3040096051
9681260
3004111573
2124215
3010220595
3004207966
1220592
3003790304
3011163668
1313046
3010173425
3013247477
3010419931
3006891655
3004837686
2015691
3016463905
2648045
1319211
2029386
3003902943
9680794
3007146453
3016678045
3004859241
3009906660
3010532612
3015225571
3006082230
3000247987
9710641
3014246639
9681442
1000121056
3011137372
3015309643
3014222368
3032916632
2011171
1721504
1219930
2528981
3013526170
3003775027
1528319
3005987240
1320894
1016427
3009051888

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code FGE

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K241888	Single-use Balloon Dilatation Catheter	Leo Medical Co., Ltd.	2024-12-20
K241801	Tornus ES	Asahi Intecc Co., Ltd.	2024-12-17
K240464	WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV	Boston Scientific	2024-08-30
K233079	Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)	Cook Ireland, Ltd.	2024-06-14