510(k) K001258
- Device
- BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM
- Applicant
- CORDIS CORP.
- 510(k) number
- K001258
- Product code
- FGE
- Decision
- Se - With Limitations (SESU)
- Decision date
- 2000-06-27
- Date received
- 2000-04-18
- 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
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DEAN A KNIGHT
- Address
- 7 Powderhorn Dr. Warren NJ US 07059 07059
FDA Registration Numbers#
- 3013557562
- 9710641
- 1319211
- 3013162291
- 3033589330
- 9614641
- 2134265
- 1319639
- 3011458193
- 1828132
- 1000121056
- 1220477
- 3013440400
- 3009051888
- 1528319
- 1317547
- 1220592
- 3015225571
- 8010047
- 3000247987
- 9680794
- 3011050570
- 3005580113
- 1417485
- 3006260740
- 1644312
- 3009763019
- 1724474
- 3002807314
- 3011642792
- 3003775027
- 9681477
- 2246552
- 3008492676
- 9680809
- 3040096051
- 2183870
- 1000523114
- 2648045
- 3005987240
- 1531050
- 3010419931
- 3004129994
- 3001845648
- 3013337852
- 3010532612
- 3003902943
- 3004837686
- 3032916632
- 3021009035
- 3007695959
- 2528981
- 3014246639
- 3009526575
- 3004859241
- 3002504068
- 3016463905
- 9681442
- 3030733800
- 1037905
- 3011163668
- 1222168
- 3013152301
- 3012536737
- 3014222368
- 2126666
- 3009121749
- 3007146453
- 1225687
- 2939561
- 3008040402
- 3009906660
- 2024168
- 3003790304
- 1000393132
- 3002807090
- 3031276312
- 2029386
- 3014769442
Source Documents#
Other 510(k) Records For Product Code FGE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254179 | Drainage Catheter | Canyon Medical, Inc. | 2026-09-18 |
| K262913 | Protégé™ EverFlex™ Self-expanding Peripheral Stent System | Medtronic, Inc. | 2026-09-17 |
| K260835 | ARCHIMEDES Biodegradable Stent (Medium) | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 2026-07-27 |
| K253393 | Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019 | Hangzhou AGS MedTech Co., Ltd. | 2026-06-24 |
| 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 |
Legacy Summary#
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FDA Review#
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