Panels › Gastroenterology, Urology › Product code FBK · Class 2
Endoscopic Injection Needle, Gastroenterology-Urology
Regulation 876.1500
3510(k)s in 12 months (89 all time)
1recalls in 12 months (43 all time)
38recalls that name a 510(k)
Top companies in FBK
| Company | 510(k)s | Recalls |
|---|---|---|
| Aomori Olympus Co., Ltd. | 0 | 20 |
| Hobbs Medical, Inc. | 0 | 15 |
| Boston Scientific Corp | 4 | 3 |
| Carbon Medical Technologies, Inc. | 5 | 0 |
| Wilson-Cook Medical, Inc. | 4 | 1 |
| Advanced Uroscience, Inc. | 3 | 0 |
| Enteric Medical Technologies | 3 | 0 |
| Mill-Rose Laboratory | 3 | 0 |
| Olympus Medical Systems Corp. | 3 | 0 |
| Uroplasty, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 29, 2026 | K260262 | Injection Needle Mirco-Tech (Nanjing) Co., Ltd., CN | FBK |
| Mar 31, 2026 | K253598 | InjecSURE Injection System Carbon Medical Technologies, Inc. | FBK |
| Dec 2, 2025 | K252021 | Disposable Endoscopic Injection Needles Changzhou New Med Micro-Medtech Co., Ltd., CN | FBK |
| Oct 16, 2025 | K252247 | Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max S Olympus Medical Systems Corporation, JP | FBK |
| Feb 27, 2025 | K241595 | EzVu Visual Vasopressor injector (EV-19) Veol Medical Technologies Pvt , Ltd., IN | FBK |
| Oct 4, 2024 | K240675 | Endoscopic Injection Needles Promisemed Hangzhou Meditech Co., Ltd., CN | FBK |
| Aug 27, 2024 | K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201) Laborie Medical Technologies, Corp. | FBK |
| Apr 12, 2024 | K232200 | Disposable Injection Needles Ningbo Xinwell Medical Technology Co., Ltd., CN | FBK |
| Mar 8, 2024 | K232826 | Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteros Steris | FBK |
| Nov 9, 2023 | K232442 | Disposable Endoscope Injection Needles Zhejiang Soudon Medical Technology Co., Ltd., CN | FBK |
| Sep 27, 2023 | K230925 | Disposable Injection Needle AF series Alton (Shanghai) Medical Instruments Co., Ltd., CN | FBK |
| Apr 3, 2023 | K222006 | Sclerotherapy & Endoscopic Needles G-Flex Europe Sprl, BE | FBK |
| Dec 21, 2022 | K221054 | CORE-INJECTOR Incore Co., Ltd., KR | FBK |
| Sep 2, 2022 | K221085 | LiNA OperaScope Needle Lina Medical Aps, DK | FBK |
| Aug 19, 2022 | K220292 | Disposable Endoscope Injection Needle Yangzhou Fartley Medical Instrument Technology Co., Ltd., CN | FBK |
| Jul 29, 2022 | K213914 | Injection Needle Jiangsu Vedkang Medical Science and Technology Co., Ltd., CN | FBK |
| Jun 2, 2022 | K213239 | Endoscopic Injection Needle Beijing Zksk Technology Co., Ltd., CN | FBK |
| Feb 23, 2022 | K212668 | Sclerotherapy Needle Zhejiang Chuangxiang Medical Technology Co., Ltd., CN | FBK |
| May 28, 2021 | K210917 | Single Use Injection Needle Anrei Medical (Hangzhou) Co., Ltd., CN | FBK |
| Apr 28, 2020 | K192498 | Single Use Injector Olympus Medical Systems Corp., JP | FBK |
| Feb 27, 2020 | K190032 | Disposable Sclerotherapy Needle Hangzhou AGS MedTech Co., Ltd., CN | FBK |
| Dec 19, 2019 | K190829 | Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) Wilson-Cook Medical Inc./Cook Endoscopy | FBK |
| Dec 21, 2018 | K181690 | Clear-Jet Injection Catheter Finemedix Co., Ltd., KR | FBK |
| May 3, 2018 | K180214 | Repris Bladder Injection System Uro-1, Inc. | FBK |
| Aug 23, 2017 | K172227 | Endoscopic Injection Needle Carbon Medical Technologies, Inc. | FBK |
| Jul 28, 2017 | K171602 | Williams Cystoscopic Injection Needle Cook Incorporated | FBK |
| Jul 7, 2017 | K171454 | Interject Injection Therapy Needle Catheter Boston Scientific Corporation | FBK |
| Feb 12, 2016 | K153625 | Single Use Injector NM600/610 Olympus Medical Systems Corp., JP | FBK |
| Feb 8, 2016 | K151475 | EndoChoice Select Injection Needle Endochoice, Inc. | FBK |
| Oct 15, 2015 | K152035 | iSnare system-Lariat United States Endoscopy Group, Inc. | FBK |
| Jun 2, 2015 | K150434 | Injection Needle Micro-Tech (Nanjing) Co., Ltd., CN | FBK |
| Jan 15, 2015 | K142144 | DISPOSABLE INJECTION NEEDLE Wilson Instruments (Shanghai) Company Limited, CN | FBK |
| May 13, 2014 | K133148 | BIOMARC COAXIAL NEEDLE Carbon Medical Technologies, Inc. | FBK |
| Jan 17, 2014 | K132065 | INJECTION NEEDLE Endochoice, Inc. | FBK |
| Aug 3, 2012 | K121337 | UROPLASTY RIGID ENDOSCPIC NEEDLES Uroplasty, Inc. | FBK |
| Feb 14, 2012 | K113634 | INJEKT CYSTO FLEXIBLE INJECTION NEEDLE Cook Ireland, Ltd., IE | FBK |
| Jul 19, 2011 | K111495 | COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K Wilson-Cook Medical, Inc. | FBK |
| Nov 30, 2009 | K092090 | ERBELIFT HAND PUMP AND FLEXIBLE PROBE Byrne Medical, Inc. | FBK |
| Jul 21, 2009 | K090830 | LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP Laborie Medical Technologies, Ltd. | FBK |
| Jun 30, 2009 | K091391 | UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518 Uroplasty, Inc. | FBK |
| Apr 23, 2009 | K090217 | BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 Coloplast A/S | FBK |
| Sep 25, 2008 | K082319 | INJEKT FILIFORM INJECTION NEEDLE Cook Urological, Inc. | FBK |
| Jul 3, 2006 | K061222 | INJECTRA INJECTION NEEDLE Medi-Globe Corp. | FBK |
| Oct 27, 2005 | K043383 | N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110 Physion, Inc. | FBK |
| Aug 29, 2005 | K051905 | UROPLASTY RIGID ENDOSCOPIC NEEDLE Uroplasty, Inc. | FBK |
| Apr 6, 2005 | K050688 | TEGRESS IMPLANT NEEDLE C.R. Bard, Inc. | FBK |
| Nov 9, 2004 | K042882 | ENTERYX INJECTION CATHETER Boston Scientific Corp | FBK |
| Nov 5, 2004 | K042615 | CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE Carbon Medical Technologies, Inc. | FBK |
| Oct 4, 2004 | K031238 | VARICES NEEDLE Scandimed. A.S. | FBK |
| Apr 30, 2003 | K030451 | CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE Carbon Medical Technologies, Inc. | FBK |
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