510(k) K240464
- Device
- WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV
- Applicant
- Boston Scientific
- 510(k) number
- K240464
- Product code
- FGE
- Decision
- Unknown (SESU)
- Decision date
- 2024-08-30
- Date received
- 2024-02-16
- 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
- Katherine Swanson
- Address
- 300 Boston Scientific Way Marborough 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
Source Documents
Other 510(k) Records For Product Code FGE
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253832 | Dilation Balloon Catheter | Mirco-Tech (Nanjing) Co., Ltd. | 2026-04-24 |
| K251658 | Endoflux Biliary & Pancreatic Stent Sets | Medi-Globe GmbH | 2026-04-16 |
| K253987 | BARE Wireguided Balloon Dilation Catheter (1235) | GIE Medical | 2026-03-13 |
| K253132 | Single use stone retrieval balloons | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2026-03-06 |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent | Taewoong Medical Co., Ltd. | 2025-12-29 |
| K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G | Bioteque Corporation | 2025-12-22 |
| K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) | Olympus Medical Systems Corporation | 2025-10-21 |
| K251229 | EndoFixTissue Fixation System | Softac Medical Technologies | 2025-08-20 |
| K243412 | ARCHIMEDES Biodegradable Pancreatic Stent | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 2025-07-16 |
| K251291 | Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers | Boston Scientific | 2025-07-03 |
| K242845 | EGIS Biliary Double Bare Stent (BDB080405) | S&G Biotech, Inc. | 2025-06-25 |
| K241888 | Single-use Balloon Dilatation Catheter | Leo Medical Co., Ltd. | 2024-12-20 |
| K241801 | Tornus ES | Asahi Intecc Co., Ltd. | 2024-12-17 |
| K242950 | WallFlex Biliary PLUS RX Stent System | Boston Scientific | 2024-12-06 |
| 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 |