| K252646 | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) | Olympus Medical Systems Corp. | 2025-10-24 |
| K250994 | ClearTip FNA and FNB Types | Finemedix Co., Ltd. | 2025-08-21 |
| K241209 | EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) | Cook Ireland, Ltd. | 2024-07-29 |
| K231422 | Precision GI | Limaca Medical, Ltd. | 2023-08-28 |
| K231267 | ClearTip | Finemedix Co., Ltd. | 2023-06-30 |
| K230909 | EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) | Cook Ireland, Ltd. | 2023-05-30 |
| K212423 | EndoDrill® Model X | Bibbinstruments AB | 2023-03-29 |
| K212822 | Disposable Coaxial Biopsy Needle | Suzhou Leapmed Healthcare Corporation | 2022-07-06 |
| K212819 | Disposable Biopsy Refill Needle | Suzhou Leapmed Healthcare Corporation | 2022-07-06 |
| K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle | Cook Ireland, Ltd. | 2021-05-20 |
| K191472 | Biopsy Needle | Ushare Medical, Inc. | 2020-01-29 |
| K181756 | Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle | Apriomed AB | 2018-12-18 |
| K180668 | Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N | Olympus Medical Systems Corp. | 2018-11-15 |
| K180363 | Clear-Tip EUS-FNA | Finemedix Co., Ltd. | 2018-11-01 |
| K181994 | Single Use Aspiration Needle NA-U201H | Olympus Medical Systems Corp. | 2018-10-31 |
| K180449 | Single Use Aspiration Needle NA-U200H | Olympus Medical Systems Corp. | 2018-06-08 |
| K180037 | Beacon EUS Access System | Covidien, LLC | 2018-04-26 |
| K171956 | Sterile Endoscope Biopsy Sampling Needle | Changzhou Detain Medical Devices Co., Ltd. | 2017-12-12 |
| K171596 | ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle | Wilson-Cook Medical, Inc. | 2017-08-04 |
| K160890 | Howell Biliary Introducer Needle | Wilson-Cook Medical, Inc. | 2017-06-14 |
| K160423 | Perineologic Access Needle | Corbin Clinical Resources, LLC | 2016-09-02 |
| K160098 | Single Use Aspiration Needle NA-U401SX | Olympus Medical Systems Corp. | 2016-03-22 |
| K160229 | Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle | Cook Ireland, Ltd. | 2016-03-21 |
| K151738 | Single Use Aspiration Needle NA-U200H | Olympus Medical Systems Corp. | 2015-11-20 |
| K151895 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle | Boston Scientific Corporation | 2015-10-22 |
| K151373 | Corvocet Coaxial Introducer | Merit Medical Systems, Inc. | 2015-08-07 |
| K150891 | BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System | Covidien, LLC( Formerly Beacon Endoscopic Corp.) | 2015-05-01 |
| K142688 | Echotip Procore HD Ultrasound Biopsy Needle | Cook Ireland, Ltd. | 2014-12-19 |
| K131925 | HS NOTA | H.S. Hospital Services S.P.A. | 2014-10-10 |
| K141894 | SHARKCORE FINE NEEDLE BIOPSY SYSTEM | Covidien, LLC( Formerly Beacon Endoscopic Corp.) | 2014-10-06 |