FDA 510(k) Applications for Medical Device Product Code "FBK"
(Endoscopic Injection Needle, Gastroenterology-Urology)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K002323 | ADVANCED UROSCIENCE, INC. | ADVANCED UROSCIENCE INJECTION NEEDLE | 07/31/2000 |
| K982890 | ADVANCED UROSCIENCE, INC. | ADVANCED UROSCIENCE INJECTION NEEDLE | 10/26/1998 |
| K002573 | ADVANCED UROSCIENCE, INC. | ADVANCED UROSCIENCE INNERSHEATH | 11/16/2000 |
| K230925 | Alton (Shanghai) Medical Instruments Co. Ltd | Disposable Injection Needle AF series | 09/27/2023 |
| K210917 | Anrei Medical (Hangzhou) Co., Ltd. | Single Use Injection Needle | 05/28/2021 |
| K213239 | Beijing ZKSK Technology Co.,Ltd | Endoscopic Injection Needle | 06/02/2022 |
| K042882 | BOSTON SCIENTIFIC CORP. | ENTERYX INJECTION CATHETER | 11/09/2004 |
| K961846 | BOSTON SCIENTIFIC CORP. | NEEDLE CATHETER | 07/15/1996 |
| K171454 | Boston Scientific Corporation | Interject Injection Therapy Needle Catheter | 07/07/2017 |
| K092090 | BYRNE MEDICAL INC. | ERBELIFT HAND PUMP AND FLEXIBLE PROBE | 11/30/2009 |
| K050688 | C.R. BARD, INC. | TEGRESS IMPLANT NEEDLE | 04/06/2005 |
| K133148 | CARBON MEDICAL TECHNOLOGIES, INC. | BIOMARC COAXIAL NEEDLE | 05/13/2014 |
| K042615 | CARBON MEDICAL TECHNOLOGIES, INC. | CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE | 11/05/2004 |
| K030451 | CARBON MEDICAL TECHNOLOGIES, INC. | CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE | 04/30/2003 |
| K172227 | Carbon Medical Technologies, Inc. | Endoscopic Injection Needle | 08/23/2017 |
| K090217 | COLOPLAST A/S | BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 | 04/23/2009 |
| K171602 | Cook Incorporated | Williams Cystoscopic Injection Needle | 07/28/2017 |
| K113634 | COOK IRELAND LTD | INJEKT CYSTO FLEXIBLE INJECTION NEEDLE | 02/14/2012 |
| K022484 | COOK UROLOGICAL, INC. | COOK INJECTION NEEDLE | 10/25/2002 |
| K082319 | COOK UROLOGICAL, INC. | INJEKT FILIFORM INJECTION NEEDLE | 09/25/2008 |
| K012977 | ENDO-THERAPEUTICS, INC. | VARICES INJECTION NEEDLE | 11/02/2001 |
| K151475 | ENDOCHOICE, INC. | EndoChoice Select Injection Needle | 02/08/2016 |
| K132065 | ENDOCHOICE, INC. | INJECTION NEEDLE | 01/17/2014 |
| K000646 | ENTERIC MEDICAL TECHNOLOGIES | DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE | 04/13/2000 |
| K013712 | ENTERIC MEDICAL TECHNOLOGIES | ENTERYX INJECTOR | 05/31/2002 |
| K002778 | ENTERIC MEDICAL TECHNOLOGIES, INC. | ENTERIC INJECTION CATHETER WITH IRRIGATION | 11/22/2000 |
| K181690 | Finemedix Co. Ltd. | Clear-Jet Injection Catheter | 12/21/2018 |
| K222006 | G-Flex Europe SPRL | Sclerotherapy & Endoscopic Needles | 04/03/2023 |
| K001146 | GENY MEDICAL, INC. | GENYX FLEXIBLE INJECTION NEEEDLE | 06/30/2000 |
| K990996 | GENYX MEDICAL, INC. | GENYX MEDICAL INJECTION NEEDLE | 06/18/1999 |
| K190032 | Hangzhou AGS MedTech CO., Ltd | Disposable Sclerotherapy Needle | 02/27/2020 |
| K010448 | HORIZONS INTL. CORP. | HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES | 05/16/2001 |
| K221054 | Incore Co., Ltd. | CORE-INJECTOR | 12/21/2022 |
| K213914 | Jiangsu Vedkang Medical Science and Technology Co.,Ltd | Injection Needle | 07/29/2022 |
| K241523 | Laborie Medical Technologies Corp. | injeTAK Adjustable Tip Needle (DIS199; DIS201) | 08/27/2024 |
| K090830 | LABORIE MEDICAL TECHNOLOGIES, LTD. | LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP | 07/21/2009 |
| K221085 | LiNA Medical ApS | LiNA OperaScope Needle | 09/02/2022 |
| K960519 | MARTECH MEDICAL PRODUCTS, INC. | MARTECH ENDOSCOPIC INJECTION NEEDLE | 05/01/1996 |
| K955558 | MEDI-GLOBE CORP. | GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES | 02/29/1996 |
| K061222 | MEDI-GLOBE CORP. | INJECTRA INJECTION NEEDLE | 07/03/2006 |
| K150434 | Micro-Tech (Nanjing) CO., Ltd. | Injection Needle | 06/02/2015 |
| K232200 | Ningbo Xinwell Medical Technology Co., Ltd | Disposable Injection Needles | 04/12/2024 |
| K192498 | Olympus Medical Systems Corp. | Single Use Injector | 04/28/2020 |
| K153625 | OLYMPUS MEDICAL SYSTEMS CORP. | Single Use Injector NM600/610 | 02/12/2016 |
| K011484 | OLYMPUS OPTICAL CO., LTD. | OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 | 08/10/2001 |
| K043383 | PHYSION, INC. | N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110 | 10/27/2005 |
| K240675 | Promisemed Hangzhou Meditech Co., Ltd. | Endoscopic Injection Needles | 10/04/2024 |
| K031238 | SCANDIMED. A.S. | VARICES NEEDLE | 10/04/2004 |
| K232826 | STERIS | Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813) | 03/08/2024 |
| K152035 | United States Endoscopy Group, Inc | iSnare system-Lariat | 10/15/2015 |
| K180214 | URO-1, Inc. | Repris Bladder Injection System | 05/03/2018 |
| K051905 | UROPLASTY, INC. | UROPLASTY RIGID ENDOSCOPIC NEEDLE | 08/29/2005 |
| K091391 | UROPLASTY, INC. | UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518 | 06/30/2009 |
| K121337 | UROPLASTY, INC. | UROPLASTY RIGID ENDOSCPIC NEEDLES | 08/03/2012 |
| K241595 | Veol Medical Technologies Pvt Ltd. | EzVu Visual Vasopressor injector (EV-19) | 02/27/2025 |
| K142144 | WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED | DISPOSABLE INJECTION NEEDLE | 01/15/2015 |
| K111495 | WILSON-COOK MEDICAL INC. | COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K | 07/19/2011 |
| K190829 | Wilson-Cook Medical, Inc. / Cook Endoscopy | Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) | 12/19/2019 |
| K983765 | XIMED/PROSURE/INJECTX | INJECTION NEEDLE PROBE/DEVICE-TUNIS | 12/11/1998 |
| K220292 | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Disposable Endoscope Injection Needle | 08/19/2022 |
| K212668 | Zhejiang Chuangxiang Medical Technology Co., LTD. | Sclerotherapy Needle | 02/23/2022 |
| K232442 | Zhejiang Soudon Medical Technology Co.,Ltd | Disposable Endoscope Injection Needles | 11/09/2023 |
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