FDA Product Code
FDA Product Code FCG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1075
510(k) Clearances — 133 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252646 | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) | Olympus Medical Systems Corp. | 2025-10-24 | Traditional | PDF ↗ |
| K250994 | ClearTip FNA and FNB Types | Finemedix Co., Ltd. | 2025-08-21 | Traditional | PDF ↗ |
| K241209 | EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19) | Cook Ireland, Ltd. | 2024-07-29 | Traditional | PDF ↗ |
| K231422 | Precision GI | Limaca Medical, Ltd. | 2023-08-28 | Traditional | PDF ↗ |
| K231267 | ClearTip | Finemedix Co., Ltd. | 2023-06-30 | Traditional | PDF ↗ |
| K230909 | EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22) | Cook Ireland, Ltd. | 2023-05-30 | Traditional | PDF ↗ |
| K212423 | EndoDrill® Model X | Bibbinstruments AB | 2023-03-29 | Traditional | PDF ↗ |
| K212822 | Disposable Coaxial Biopsy Needle | Suzhou Leapmed Healthcare Corporation | 2022-07-06 | Traditional | PDF ↗ |
| K212819 | Disposable Biopsy Refill Needle | Suzhou Leapmed Healthcare Corporation | 2022-07-06 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K191472 | Biopsy Needle | Ushare Medical, Inc. | 2020-01-29 | Traditional | PDF ↗ |
| K181756 | Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle | Apriomed AB | 2018-12-18 | Traditional | PDF ↗ |
| K180668 | Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N | Olympus Medical Systems Corp. | 2018-11-15 | Traditional | PDF ↗ |
| K180363 | Clear-Tip EUS-FNA | Finemedix Co., Ltd. | 2018-11-01 | Traditional | PDF ↗ |
| K181994 | Single Use Aspiration Needle NA-U201H | Olympus Medical Systems Corp. | 2018-10-31 | Traditional | PDF ↗ |
| K180449 | Single Use Aspiration Needle NA-U200H | Olympus Medical Systems Corp. | 2018-06-08 | Traditional | PDF ↗ |
| K180037 | Beacon EUS Access System | Covidien, LLC | 2018-04-26 | Traditional | PDF ↗ |
| K171956 | Sterile Endoscope Biopsy Sampling Needle | Changzhou Detain Medical Devices Co., Ltd. | 2017-12-12 | Traditional | PDF ↗ |
| K171596 | ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle | Wilson-Cook Medical, Inc. | 2017-08-04 | Traditional | PDF ↗ |
| K160890 | Howell Biliary Introducer Needle | Wilson-Cook Medical, Inc. | 2017-06-14 | Traditional | PDF ↗ |
| K160423 | Perineologic Access Needle | Corbin Clinical Resources, LLC | 2016-09-02 | Traditional | PDF ↗ |
| K160098 | Single Use Aspiration Needle NA-U401SX | Olympus Medical Systems Corp. | 2016-03-22 | Traditional | PDF ↗ |
| K160229 | Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle | Cook Ireland, Ltd. | 2016-03-21 | Traditional | PDF ↗ |
| K151738 | Single Use Aspiration Needle NA-U200H | Olympus Medical Systems Corp. | 2015-11-20 | Traditional | PDF ↗ |
| K151895 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle | Boston Scientific Corporation | 2015-10-22 | Traditional | PDF ↗ |
| K151373 | Corvocet Coaxial Introducer | Merit Medical Systems, Inc. | 2015-08-07 | Traditional | PDF ↗ |
| K150891 | BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System | Covidien, LLC( Formerly Beacon Endoscopic Corp.) | 2015-05-01 | Special | PDF ↗ |
| K142688 | Echotip Procore HD Ultrasound Biopsy Needle | Cook Ireland, Ltd. | 2014-12-19 | Traditional | PDF ↗ |
| K131925 | HS NOTA | H.S. Hospital Services S.P.A. | 2014-10-10 | Traditional | PDF ↗ |
| K141894 | SHARKCORE FINE NEEDLE BIOPSY SYSTEM | Covidien, LLC( Formerly Beacon Endoscopic Corp.) | 2014-10-06 | Traditional | PDF ↗ |
| K133763 | SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM | Medi-Globe Corporation | 2014-05-15 | Traditional | PDF ↗ |
| K140137 | SAFETY BIOPSY NEEDLE SYSTEM | Pfm Medical, Inc. | 2014-03-25 | Traditional | PDF ↗ |
| K133008 | BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED, | Beacon Endoscopic | 2013-11-20 | Traditional | PDF ↗ |
| K103694 | TISSUE SAMPLING NEEDLE | United States Endoscopy Group, Inc. | 2011-07-27 | Traditional | PDF ↗ |
| K103668 | BNX FINE NEEDLE ASPIRATION SYSTEM | Boston Endoscopic Engineering | 2010-12-30 | Traditional | PDF ↗ |
| K100712 | RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE | Boston Scientific Corporation | 2010-03-30 | Traditional | PDF ↗ |
| K093195 | ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O | Cook Ireland, Ltd. | 2010-01-21 | Traditional | PDF ↗ |
| K092359 | ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A | Cook Ireland, Ltd. | 2009-11-02 | Traditional | PDF ↗ |
| K091257 | MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM | Medi-Globe Corporation | 2009-05-08 | Traditional | PDF ↗ |
| K083802 | SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025 | Medi-Globe Corporation | 2009-03-20 | Traditional | PDF ↗ |
| K083330 | ECHOTIP ULTRA ULTRASOUND NEEDLE | Cook Endoscopy | 2009-02-06 | Traditional | PDF ↗ |
| K081323 | BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 | B-K Medical Aps | 2008-07-22 | Traditional | PDF ↗ |
| K073399 | TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE | Envisioneering, LLC | 2007-12-21 | Special | PDF ↗ |
| K062979 | THYROSAMPLER | Acd Medical Innovation Corp. | 2007-05-30 | Traditional | PDF ↗ |
| K070179 | TROKABONE, TROKABONE STERNAL | PAJUNK GmbH Medizintechnologie | 2007-03-07 | Traditional | PDF ↗ |
| K070129 | SONOTIP II ULTRASOUND NEEDLE SYSTEM | Medi-Globe Corporation | 2007-01-31 | Traditional | PDF ↗ |
| K051506 | MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY | Sterylab S.R.L. | 2005-07-27 | Traditional | PDF ↗ |
| K050135 | K-C HEMOSTATIC BIOPSY SYSTEM | Bioengineering Consultants , Ltd. | 2005-07-13 | Traditional | PDF ↗ |
| K051247 | SONOTIP II ULTRASOUND NEEDLE SYSTEM | Medi-Globe Corp. | 2005-06-16 | Special | PDF ↗ |
| K050503 | SINGLE USE ASPIRATION NEEDLE NA-201SX-4022 | Olympus Medical Systems Corporation | 2005-05-12 | Traditional | PDF ↗ |
| K050120 | EASY CORE BIOPSY SYSTEM II | Boston Scientific Corp | 2005-02-08 | Special | PDF ↗ |
| K040893 | EASY CORE BIOPSY SYSTEM | Boston Scientific Corp | 2004-05-06 | Special | PDF ↗ |
| K024120 | MODIFICATION TO TEMNO BIOPSY NEEDLES | Allegiance Healthcare Corp. | 2003-01-15 | Special | PDF ↗ |
| K023272 | DISPOSABLE ASPIRATION NEEDLE NA-200H | The Olympus Optical Co. | 2002-12-23 | Traditional | PDF ↗ |
| K021847 | BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES | Biopsy Sciences, LLC | 2002-09-03 | Traditional | PDF ↗ |
| K021525 | TOPCUT | H.S. Hospital Service S.R.L. | 2002-07-12 | Traditional | PDF ↗ |
| K013109 | SONOPSY | Hakko Medical Co., Ltd. | 2002-03-12 | Traditional | PDF ↗ |
| K013070 | JAMSHIDI BIOPSY NEEDLE | H.S. Hospital Services S.P.A. | 2001-12-12 | Traditional | PDF ↗ |
| K013071 | SECURCUT ASPIRATION BIOPSY NEEDLE | H.S. Hospital Services S.P.A. | 2001-12-12 | Traditional | PDF ↗ |
| K013069 | BIOSPEED | H.S. Hospital Services S.P.A. | 2001-12-12 | Traditional | PDF ↗ |
| K012864 | INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836 | Boston Scientific Corp | 2001-10-24 | Traditional | PDF ↗ |
| K013356 | WILSON-COOK ULTRASOUND BIOPSY NEEDLE | Wilson-Cook Medical, Inc. | 2001-10-19 | Special | PDF ↗ |
| K012358 | CHIBA NEEDLE | Ispg, Inc. | 2001-10-15 | Traditional | PDF ↗ |
| K011075 | EASYBELL | Biopsybell S.A.S. | 2001-06-27 | Traditional | PDF ↗ |
| K011270 | AUTOMATED CORE BIOPSY DEVICE | Promex, Inc. | 2001-06-22 | Traditional | PDF ↗ |
| K002946 | SILENT BIOPSY NEEDLE | H.S. Hospital Service S.R.L. | 2000-12-19 | Traditional | PDF ↗ |
| K002947 | BIOMOL ASPIRATION BIOPSY NEEDLE | H.S. Hospital Service S.R.L. | 2000-12-19 | Traditional | PDF ↗ |
| K002944 | PRECISA BIOPSY NEEDLE | H.S. Hospital Service S.R.L. | 2000-12-19 | Traditional | PDF ↗ |
| K991672 | OLYMPUS NA-10J-KB ASPIRATION NEEDLE | Olympus America, Inc. | 1999-11-03 | Traditional | PDF ↗ |
| K990220 | MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM | Medi-Globe Corp. | 1999-03-31 | Traditional | PDF ↗ |
| K983218 | N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE | Avid N.I.T., Inc. | 1998-11-06 | Traditional | PDF ↗ |
| K981889 | WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE | Worldwide Medical Technologies, LLC | 1998-07-31 | Traditional | PDF ↗ |
| K963565 | MRI NEEDLES | Cook, Inc. | 1997-07-14 | Traditional | PDF ↗ |
| K971842 | COAXIAL NEEDLE | United States Endoscopy Group, Inc. | 1997-06-20 | Traditional | PDF ↗ |
| K970563 | OLYMPUS NA-10J-1 ASPIRATION NEEDLE | Olympus America, Inc. | 1997-04-11 | Traditional | PDF ↗ |
| K963894 | SMARTGUIDE | Ferguson Medical | 1997-03-11 | Traditional | PDF ↗ |
| K961897 | WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE | Wilson-Cook Medical, Inc. | 1997-01-29 | Traditional | PDF ↗ |
| K962569 | BIOMID BONE MARROW BIOPSY NEEDLE | Gallini Intl., Inc. | 1996-11-27 | Traditional | PDF ↗ |
| K962570 | ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE | Gallini Intl., Inc. | 1996-11-27 | Traditional | PDF ↗ |
| K962568 | ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES | Gallini Intl., Inc. | 1996-11-25 | Traditional | PDF ↗ |
| K962905 | TX BIOPSY NEEDLE | Gallini S.R.L. | 1996-10-11 | Traditional | PDF ↗ |
| K961185 | DAUM BIOPSYNEEDLE | Ferguson Medical | 1996-04-30 | Traditional | PDF ↗ |
| K960317 | LAURUS NEEDLE CORE BIOPSY SYSTEM | Laurus Medical Corp. | 1996-03-15 | Traditional | PDF ↗ |
| K943304 | 3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY | Olympus America, Inc. | 1995-12-20 | Traditional | PDF ↗ |
| K951421 | GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES | Global Medical Products, Ltd. | 1995-11-16 | Traditional | PDF ↗ |
| K954596 | PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM | Promedical , Ltd. | 1995-10-07 | Traditional | PDF ↗ |
| K954231 | AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT | Promex, Inc. | 1995-09-22 | Traditional | PDF ↗ |
| K954155 | GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLE | Promex, Inc. | 1995-09-12 | Traditional | PDF ↗ |
| K941722 | FNA BIOPSY NEEDLE | Betta Medical, Inc. | 1995-05-22 | Traditional | PDF ↗ |
| K951598 | PRO-B BIOPSY NEEDLE | Promedical , Ltd. | 1995-04-21 | Traditional | PDF ↗ |
| K950982 | B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE | B. Braun of America, Inc. | 1995-04-04 | Traditional | PDF ↗ |
| K950810 | RUTNER BIOPSY DEVICE | Cook Urological, Inc. | 1995-03-06 | Traditional | PDF ↗ |
| K935844 | GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA | Medi-Globe Corp. | 1995-02-13 | Traditional | PDF ↗ |
| K945813 | BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-02-07 | Traditional | PDF ↗ |
| K945921 | ECHO STAR NEEDLE SET | Ideamatrix | 1995-02-01 | Traditional | PDF ↗ |
| K944944 | CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE | Promedical , Ltd. | 1994-12-21 | Traditional | PDF ↗ |
| K945146 | CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE | Promex, Inc. | 1994-12-21 | Traditional | PDF ↗ |
| K945133 | MODIFIED BIOPSY NEEDLE | Biopsys Medical, Inc. | 1994-11-09 | Traditional | PDF ↗ |
| K941563 | THE BIOPSY TOOL | Citation Medical Corp. | 1994-09-26 | Traditional | PDF ↗ |
| K934256 | GLOBAL MEDICAL CUTTING BIOPSY NEEDLE | Global Medical Prods, Inc. | 1994-03-28 | Traditional | PDF ↗ |
Product code FCG · Class II · Gastroenterology, Urology. Data: openFDA.