510(k) K152069
- Device
- Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter
- Applicant
- NAVILYST MEDICAL, INC.
- 510(k) number
- K152069
- Product code
- FGE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-09-24
- Date received
- 2015-07-27
- 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
- MICHAEL P. HANLEY
- Address
- 26 Forest St. Marlborough MA US 01752 01752
FDA Registration Numbers#
- 3007146453
- 3003898360
- 2024024
- 3003902943
- 3006891655
- 2528981
- 3010532612
- 3011146996
- 3012480535
- 3011642792
- 3002807314
- 3027260597
- 3035451914
- 9616099
- 1625425
- 1531050
- 1000121056
- 8010047
- 3011050570
- 3011458193
- 3006260740
- 3013162291
- 2011171
- 3014246639
- 1319639
- 2126666
- 3003775027
- 1018233
- 1928237
- 1225687
- 1219930
- 1313046
- 9616684
- 1220477
- 3010220595
- 3009906660
- 3004837686
- 2183870
- 3005580113
- 3000247987
- 3002504068
- 1222168
- 3021009035
- 3010273872
- 3011347300
- 3003790304
- 3011163668
- 3009018440
- 2124215
- 1123137
- 3004207966
- 2020394
- 3014222368
- 1016427
- 3010419931
- 3004111573
- 3004129994
- 2939561
- 1644312
- 1037905
- 3003910212
- 3032916632
- 1643817
- 3013152301
- 3005089785
- 9680809
- 1820334
- 3009763019
- 1417485
- 1061124
- 3004859241
- 1000523114
- 3016463905
- 3014769442
- 3016678045
- 2134265
- 3010173425
- 1828132
- 2015691
- 3030733800
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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