| Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) (K252646) | Olympus Medical Systems Corp. | 2025-10-24 |
| ClearTip FNA and FNB Types (K250994) | Finemedix Co., Ltd. | 2025-08-21 |
| EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) (K241209) | Cook Ireland, Ltd. | 2024-07-29 |
| Precision GI (K231422) | Limaca Medical, Ltd. | 2023-08-28 |
| ClearTip (K231267) | Finemedix Co., Ltd. | 2023-06-30 |
| EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) (K230909) | Cook Ireland, Ltd. | 2023-05-30 |
| EndoDrill® Model X (K212423) | Bibbinstruments AB | 2023-03-29 |
| Disposable Biopsy Refill Needle (K212819) | Suzhou Leapmed Healthcare Corporation | 2022-07-06 |
| Disposable Coaxial Biopsy Needle (K212822) | Suzhou Leapmed Healthcare Corporation | 2022-07-06 |
| 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 (K210476) | Cook Ireland, Ltd. | 2021-05-20 |
| Biopsy Needle (K191472) | Ushare Medical, Inc. | 2020-01-29 |
| Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle (K181756) | Apriomed AB | 2018-12-18 |
| Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N (K180668) | Olympus Medical Systems Corp. | 2018-11-15 |
| Clear-Tip EUS-FNA (K180363) | Finemedix Co., Ltd. | 2018-11-01 |
| Single Use Aspiration Needle NA-U201H (K181994) | Olympus Medical Systems Corp. | 2018-10-31 |
| Single Use Aspiration Needle NA-U200H (K180449) | Olympus Medical Systems Corp. | 2018-06-08 |
| Beacon EUS Access System (K180037) | Covidien, LLC | 2018-04-26 |
| Sterile Endoscope Biopsy Sampling Needle (K171956) | Changzhou Detain Medical Devices Co., Ltd. | 2017-12-12 |
| ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle (K171596) | Wilson-Cook Medical, Inc. | 2017-08-04 |
| Howell Biliary Introducer Needle (K160890) | Wilson-Cook Medical, Inc. | 2017-06-14 |
| Perineologic Access Needle (K160423) | Corbin Clinical Resources, LLC | 2016-09-02 |
| Single Use Aspiration Needle NA-U401SX (K160098) | Olympus Medical Systems Corp. | 2016-03-22 |
| Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle (K160229) | Cook Ireland, Ltd. | 2016-03-21 |
| Single Use Aspiration Needle NA-U200H (K151738) | Olympus Medical Systems Corp. | 2015-11-20 |
| Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle (K151895) | Boston Scientific Corporation | 2015-10-22 |
| Corvocet Coaxial Introducer (K151373) | Merit Medical Systems, Inc. | 2015-08-07 |
| BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System (K150891) | Covidien, LLC( Formerly Beacon Endoscopic Corp.) | 2015-05-01 |
| Echotip Procore HD Ultrasound Biopsy Needle (K142688) | Cook Ireland, Ltd. | 2014-12-19 |
| HS NOTA (K131925) | H.S. Hospital Services S.P.A. | 2014-10-10 |
| SHARKCORE FINE NEEDLE BIOPSY SYSTEM (K141894) | Covidien, LLC( Formerly Beacon Endoscopic Corp.) | 2014-10-06 |
| SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM (K133763) | Medi-Globe Corporation | 2014-05-15 |
| SAFETY BIOPSY NEEDLE SYSTEM (K140137) | Pfm Medical, Inc. | 2014-03-25 |
| BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED, (K133008) | Beacon Endoscopic | 2013-11-20 |
| TISSUE SAMPLING NEEDLE (K103694) | United States Endoscopy Group, Inc. | 2011-07-27 |
| BNX FINE NEEDLE ASPIRATION SYSTEM (K103668) | Boston Endoscopic Engineering | 2010-12-30 |
| RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE (K100712) | Boston Scientific Corporation | 2010-03-30 |
| ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O (K093195) | Cook Ireland, Ltd. | 2010-01-21 |
| ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A (K092359) | Cook Ireland, Ltd. | 2009-11-02 |
| MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM (K091257) | Medi-Globe Corporation | 2009-05-08 |
| SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025 (K083802) | Medi-Globe Corporation | 2009-03-20 |
| ECHOTIP ULTRA ULTRASOUND NEEDLE (K083330) | Cook Endoscopy | 2009-02-06 |
| BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 (K081323) | B-K Medical Aps | 2008-07-22 |
| TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE (K073399) | Envisioneering, LLC | 2007-12-21 |
| THYROSAMPLER (K062979) | Acd Medical Innovation Corp. | 2007-05-30 |
| TROKABONE, TROKABONE STERNAL (K070179) | PAJUNK GmbH Medizintechnologie | 2007-03-07 |
| SONOTIP II ULTRASOUND NEEDLE SYSTEM (K070129) | Medi-Globe Corporation | 2007-01-31 |
| MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY (K051506) | Sterylab S.R.L. | 2005-07-27 |
| K-C HEMOSTATIC BIOPSY SYSTEM (K050135) | Bioengineering Consultants , Ltd. | 2005-07-13 |
| SONOTIP II ULTRASOUND NEEDLE SYSTEM (K051247) | Medi-Globe Corp. | 2005-06-16 |
| SINGLE USE ASPIRATION NEEDLE NA-201SX-4022 (K050503) | Olympus Medical Systems Corporation | 2005-05-12 |
| EASY CORE BIOPSY SYSTEM II (K050120) | Boston Scientific Corp | 2005-02-08 |
| EASY CORE BIOPSY SYSTEM (K040893) | Boston Scientific Corp | 2004-05-06 |
| MODIFICATION TO TEMNO BIOPSY NEEDLES (K024120) | Allegiance Healthcare Corp. | 2003-01-15 |
| DISPOSABLE ASPIRATION NEEDLE NA-200H (K023272) | The Olympus Optical Co. | 2002-12-23 |
| BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES (K021847) | Biopsy Sciences, LLC | 2002-09-03 |
| TOPCUT (K021525) | H.S. Hospital Service S.R.L. | 2002-07-12 |
| SONOPSY (K013109) | Hakko Medical Co., Ltd. | 2002-03-12 |
| BIOSPEED (K013069) | H.S. Hospital Services S.P.A. | 2001-12-12 |
| JAMSHIDI BIOPSY NEEDLE (K013070) | H.S. Hospital Services S.P.A. | 2001-12-12 |
| SECURCUT ASPIRATION BIOPSY NEEDLE (K013071) | H.S. Hospital Services S.P.A. | 2001-12-12 |
| INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836 (K012864) | Boston Scientific Corp | 2001-10-24 |
| WILSON-COOK ULTRASOUND BIOPSY NEEDLE (K013356) | Wilson-Cook Medical, Inc. | 2001-10-19 |
| CHIBA NEEDLE (K012358) | Ispg, Inc. | 2001-10-15 |
| EASYBELL (K011075) | Biopsybell S.A.S. | 2001-06-27 |
| AUTOMATED CORE BIOPSY DEVICE (K011270) | Promex, Inc. | 2001-06-22 |
| BIOMOL ASPIRATION BIOPSY NEEDLE (K002947) | H.S. Hospital Service S.R.L. | 2000-12-19 |
| SILENT BIOPSY NEEDLE (K002946) | H.S. Hospital Service S.R.L. | 2000-12-19 |
| PRECISA BIOPSY NEEDLE (K002944) | H.S. Hospital Service S.R.L. | 2000-12-19 |
| OLYMPUS NA-10J-KB ASPIRATION NEEDLE (K991672) | Olympus America, Inc. | 1999-11-03 |
| MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM (K990220) | Medi-Globe Corp. | 1999-03-31 |
| N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE (K983218) | Avid N.I.T., Inc. | 1998-11-06 |
| WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE (K981889) | Worldwide Medical Technologies, LLC | 1998-07-31 |
| MRI NEEDLES (K963565) | Cook, Inc. | 1997-07-14 |
| COAXIAL NEEDLE (K971842) | United States Endoscopy Group, Inc. | 1997-06-20 |
| OLYMPUS NA-10J-1 ASPIRATION NEEDLE (K970563) | Olympus America, Inc. | 1997-04-11 |
| SMARTGUIDE (K963894) | Ferguson Medical | 1997-03-11 |
| WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE (K961897) | Wilson-Cook Medical, Inc. | 1997-01-29 |
| ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE (K962570) | Gallini Intl., Inc. | 1996-11-27 |
| BIOMID BONE MARROW BIOPSY NEEDLE (K962569) | Gallini Intl., Inc. | 1996-11-27 |
| ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES (K962568) | Gallini Intl., Inc. | 1996-11-25 |
| TX BIOPSY NEEDLE (K962905) | Gallini S.R.L. | 1996-10-11 |
| DAUM BIOPSYNEEDLE (K961185) | Ferguson Medical | 1996-04-30 |
| LAURUS NEEDLE CORE BIOPSY SYSTEM (K960317) | Laurus Medical Corp. | 1996-03-15 |
| 3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY (K943304) | Olympus America, Inc. | 1995-12-20 |
| GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES (K951421) | Global Medical Products, Ltd. | 1995-11-16 |
| PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM (K954596) | Promedical , Ltd. | 1995-10-07 |
| AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT (K954231) | Promex, Inc. | 1995-09-22 |
| GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLE (K954155) | Promex, Inc. | 1995-09-12 |
| FNA BIOPSY NEEDLE (K941722) | Betta Medical, Inc. | 1995-05-22 |
| PRO-B BIOPSY NEEDLE (K951598) | Promedical , Ltd. | 1995-04-21 |
| B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE (K950982) | B. Braun of America, Inc. | 1995-04-04 |
| RUTNER BIOPSY DEVICE (K950810) | Cook Urological, Inc. | 1995-03-06 |
| GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA (K935844) | Medi-Globe Corp. | 1995-02-13 |
| BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP (K945813) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-02-07 |
| ECHO STAR NEEDLE SET (K945921) | Ideamatrix | 1995-02-01 |
| CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE (K945146) | Promex, Inc. | 1994-12-21 |
| CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE (K944944) | Promedical , Ltd. | 1994-12-21 |
| MODIFIED BIOPSY NEEDLE (K945133) | Biopsys Medical, Inc. | 1994-11-09 |
| THE BIOPSY TOOL (K941563) | Citation Medical Corp. | 1994-09-26 |
| GLOBAL MEDICAL CUTTING BIOPSY NEEDLE (K934256) | Global Medical Prods, Inc. | 1994-03-28 |