510(k) K172044
- Device
- Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing Catheter, Fusion Pushing Catheter, Stent Introducer Set, Fusion Oasis One Ac
- Applicant
- Cook Ireland Ltd
- 510(k) number
- K172044
- Product code
- FGE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-02-27
- Date received
- 2017-07-06
- 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
- No
Applicant Contact#
- Contact
- Laura Graham
- Address
- O' Halloran Rd., National Technology Park Limerick IE
FDA Registration Numbers#
- 1123137
- 3009121749
- 3009906660
- 1220592
- 3032916632
- 1450395
- 3003902943
- 3030447506
- 2183870
- 1018233
- 2134265
- 9680794
- 3004091615
- 8010047
- 3005580113
- 1625425
- 2011171
- 1061124
- 3000247987
- 3004837686
- 3013337852
- 3009018440
- 3006131984
- 3013162291
- 3012536737
- 3004111573
- 1000121056
- 2939561
- 2030624
- 3004207966
- 2024168
- 3008040402
- 1724474
- 3033589330
- 3011146996
- 3010220595
- 1417485
- 9680809
- 2124215
- 2183744
- 3002504068
- 3007146453
- 2126666
- 3012480535
- 3009526575
- 9681442
- 2027111
- 3004129994
- 3014222368
- 3013440400
- 2024024
- 3011163668
- 3014246639
- 1928237
- 3006260740
- 3008492676
- 2029386
- 3015309643
- 1223925
- 3035451914
- 3008146331
- 1319639
- 3031276312
- 3011050570
- 3010419931
- 1313046
- 3016678045
- 1319211
- 3010273872
- 1820334
- 1219930
- 3007695959
- 1528319
- 3014769442
- 3010532612
- 3030733800
- 3001845648
- 1058584
- 1037905
- 3011642792
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 | EndoFix™Tissue 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 |
| K240464 | WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV | Boston Scientific | 2024-08-30 |
Legacy Summary#
summary
FDA Review#
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