| 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 |
| 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 Cathe... | Cook Ireland, Ltd. | 2024-06-14 |
| K232245 | VedDilator ^TM (3-Stage Balloon Dilation Catheter) | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2024-02-15 |
| K232596 | EndoGI S-Path Biliary Stent System | Endogi Medical, Ltd. | 2023-09-27 |
| K223354 | EGIS Biliary Single Bare Stent | S&G Biotech, Inc. | 2023-09-21 |
| K230127 | Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible | Micro-Tech (Nanjing) Co., Ltd. | 2023-09-06 |
| K223469 | WallFlex™ Biliary RX Stent System | Boston Scientific Corporation | 2023-06-15 |
| K223626 | Niti-S Biliary Speed D Stent | Taewoong Medical Co., Ltd. | 2023-05-26 |
| K222663 | MultiStage Balloon Dilatation Catheter | Dongguan TT Medical, Inc. | 2023-03-09 |
| K223592 | Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers | Boston Scientific Corporation | 2022-12-29 |
| K222627 | EndoGI S-Path Biliary Stent System | Endo GI Medical | 2022-09-28 |
| K221071 | Niti-S Biliary Slim M Stent | Taewoong Medical Co., Ltd. | 2022-06-09 |
| K213946 | Compass BDS Biliary Stent | Cook Ireland, Ltd. | 2022-05-09 |
| K211021 | Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible | Micro-Tech (Nanjing) Co., Ltd. | 2022-05-06 |
| K210419 | BIOTEQ Drainage Catheter BT-PDS-series | Bioteque Corporation | 2022-04-13 |
| K202973 | HANAROSTENT Benefit Biliary (NNN) | M.I.Tech Co., Ltd. | 2021-05-11 |