| K253987 | gie medical | BARE Wireguided Balloon Dilation Catheter (1235) | March 13, 2026 |
| K253132 | zhejiang chuangxiang medical technology co | Single use stone retrieval balloons | March 6, 2026 |
| K251123 | taewoong medical co | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent | December 29, 2025 |
| K251019 | bioteque corporation | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G | December 22, 2025 |
| K250409 | olympus medical systems corporation | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disp | October 21, 2025 |
| K251229 | softac medical technologies | EndoFixTissue Fixation System | August 20, 2025 |
| K243412 | q3 medical usa, llc (c/o q3 medical devices ltd.) | ARCHIMEDES Biodegradable Pancreatic Stent | July 16, 2025 |
| K251291 | boston scientific | Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery | July 3, 2025 |
| K242845 | s and g biotech | EGIS Biliary Double Bare Stent (BDB080405) | June 25, 2025 |
| K241888 | leo medical co | Single-use Balloon Dilatation Catheter | December 20, 2024 |
| K241801 | asahi intecc co | Tornus ES | December 17, 2024 |
| K242950 | boston scientific | WallFlex Biliary PLUS RX Stent System | December 6, 2024 |
| K240464 | boston scientific | WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX | August 30, 2024 |
| K233079 | cook ireland | Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); | June 14, 2024 |
| K232245 | jiangsu vedkang medical science and technology co | VedDilator ^TM (3-Stage Balloon Dilation Catheter) | February 15, 2024 |
| K232596 | endogi medical | EndoGI S-Path Biliary Stent System | September 27, 2023 |
| K223354 | s and g biotech | EGIS Biliary Single Bare Stent | September 21, 2023 |
| K230127 | micro-tech (nanjing) co | Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent S | September 6, 2023 |
| K223469 | boston scientific corporation | WallFlex Biliary RX Stent System | June 15, 2023 |
| K223626 | taewoong medical co | Niti-S Biliary Speed D Stent | May 26, 2023 |