FDA Product Code
FDA Product Code FBK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 89 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260262 | Injection Needle | Mirco-Tech (Nanjing) Co., Ltd. | 2026-05-29 | Traditional | PDF ↗ |
| K253598 | InjecSURE Injection System | Carbon Medical Technologies, Inc. | 2026-03-31 | Traditional | PDF ↗ |
| K252021 | Disposable Endoscopic Injection Needles | Changzhou New Med Micro-Medtech Co., Ltd. | 2025-12-02 | Traditional | PDF ↗ |
| K252247 | Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) | Olympus Medical Systems Corporation | 2025-10-16 | Traditional | PDF ↗ |
| K241595 | EzVu Visual Vasopressor injector (EV-19) | Veol Medical Technologies Pvt , Ltd. | 2025-02-27 | Traditional | PDF ↗ |
| K240675 | Endoscopic Injection Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2024-10-04 | Traditional | PDF ↗ |
| K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201) | Laborie Medical Technologies, Corp. | 2024-08-27 | Special | PDF ↗ |
| K232200 | Disposable Injection Needles | Ningbo Xinwell Medical Technology Co., Ltd. | 2024-04-12 | Traditional | PDF ↗ |
| K232826 | 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), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) | Steris | 2024-03-08 | Traditional | PDF ↗ |
| K232442 | Disposable Endoscope Injection Needles | Zhejiang Soudon Medical Technology Co., Ltd. | 2023-11-09 | Traditional | PDF ↗ |
| K230925 | Disposable Injection Needle AF series | Alton (Shanghai) Medical Instruments Co., Ltd. | 2023-09-27 | Traditional | PDF ↗ |
| K222006 | Sclerotherapy & Endoscopic Needles | G-Flex Europe Sprl | 2023-04-03 | Traditional | PDF ↗ |
| K221054 | CORE-INJECTOR | Incore Co., Ltd. | 2022-12-21 | Traditional | PDF ↗ |
| K221085 | LiNA OperaScope Needle | Lina Medical Aps | 2022-09-02 | Traditional | PDF ↗ |
| K220292 | Disposable Endoscope Injection Needle | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-08-19 | Traditional | PDF ↗ |
| K213914 | Injection Needle | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2022-07-29 | Traditional | PDF ↗ |
| K213239 | Endoscopic Injection Needle | Beijing Zksk Technology Co., Ltd. | 2022-06-02 | Traditional | PDF ↗ |
| K212668 | Sclerotherapy Needle | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022-02-23 | Traditional | PDF ↗ |
| K210917 | Single Use Injection Needle | Anrei Medical (Hangzhou) Co., Ltd. | 2021-05-28 | Traditional | PDF ↗ |
| K192498 | Single Use Injector | Olympus Medical Systems Corp. | 2020-04-28 | Traditional | PDF ↗ |
| K190032 | Disposable Sclerotherapy Needle | Hangzhou AGS MedTech Co., Ltd. | 2020-02-27 | Traditional | PDF ↗ |
| K190829 | Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) | Wilson-Cook Medical Inc./Cook Endoscopy | 2019-12-19 | Traditional | PDF ↗ |
| K181690 | Clear-Jet Injection Catheter | Finemedix Co., Ltd. | 2018-12-21 | Traditional | PDF ↗ |
| K180214 | Repris Bladder Injection System | Uro-1, Inc. | 2018-05-03 | Traditional | PDF ↗ |
| K172227 | Endoscopic Injection Needle | Carbon Medical Technologies, Inc. | 2017-08-23 | Special | PDF ↗ |
| K171602 | Williams Cystoscopic Injection Needle | Cook Incorporated | 2017-07-28 | Traditional | PDF ↗ |
| K171454 | Interject Injection Therapy Needle Catheter | Boston Scientific Corporation | 2017-07-07 | Traditional | PDF ↗ |
| K153625 | Single Use Injector NM600/610 | Olympus Medical Systems Corp. | 2016-02-12 | Traditional | PDF ↗ |
| K151475 | EndoChoice Select Injection Needle | Endochoice, Inc. | 2016-02-08 | Traditional | PDF ↗ |
| K152035 | iSnare system-Lariat | United States Endoscopy Group, Inc. | 2015-10-15 | Traditional | PDF ↗ |
| K150434 | Injection Needle | Micro-Tech (Nanjing) Co., Ltd. | 2015-06-02 | Traditional | PDF ↗ |
| K142144 | DISPOSABLE INJECTION NEEDLE | Wilson Instruments (Shanghai) Company Limited | 2015-01-15 | Traditional | PDF ↗ |
| K133148 | BIOMARC COAXIAL NEEDLE | Carbon Medical Technologies, Inc. | 2014-05-13 | Traditional | PDF ↗ |
| K132065 | INJECTION NEEDLE | Endochoice, Inc. | 2014-01-17 | Traditional | PDF ↗ |
| K121337 | UROPLASTY RIGID ENDOSCPIC NEEDLES | Uroplasty, Inc. | 2012-08-03 | Traditional | PDF ↗ |
| K113634 | INJEKT CYSTO FLEXIBLE INJECTION NEEDLE | Cook Ireland, Ltd. | 2012-02-14 | Special | PDF ↗ |
| K111495 | COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K | Wilson-Cook Medical, Inc. | 2011-07-19 | Traditional | PDF ↗ |
| K092090 | ERBELIFT HAND PUMP AND FLEXIBLE PROBE | Byrne Medical, Inc. | 2009-11-30 | Traditional | PDF ↗ |
| K090830 | LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP | Laborie Medical Technologies, Ltd. | 2009-07-21 | Traditional | PDF ↗ |
| K091391 | UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518 | Uroplasty, Inc. | 2009-06-30 | Traditional | PDF ↗ |
| K090217 | BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 | Coloplast A/S | 2009-04-23 | Traditional | PDF ↗ |
| K082319 | INJEKT FILIFORM INJECTION NEEDLE | Cook Urological, Inc. | 2008-09-25 | Traditional | PDF ↗ |
| K061222 | INJECTRA INJECTION NEEDLE | Medi-Globe Corp. | 2006-07-03 | Traditional | PDF ↗ |
| K043383 | N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110 | Physion, Inc. | 2005-10-27 | Traditional | PDF ↗ |
| K051905 | UROPLASTY RIGID ENDOSCOPIC NEEDLE | Uroplasty, Inc. | 2005-08-29 | Traditional | PDF ↗ |
| K050688 | TEGRESS IMPLANT NEEDLE | C.R. Bard, Inc. | 2005-04-06 | Special | PDF ↗ |
| K042882 | ENTERYX INJECTION CATHETER | Boston Scientific Corp | 2004-11-09 | Special | PDF ↗ |
| K042615 | CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE | Carbon Medical Technologies, Inc. | 2004-11-05 | Traditional | PDF ↗ |
| K031238 | VARICES NEEDLE | Scandimed. A.S. | 2004-10-04 | Traditional | PDF ↗ |
| K030451 | CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE | Carbon Medical Technologies, Inc. | 2003-04-30 | Traditional | PDF ↗ |
| K022484 | COOK INJECTION NEEDLE | Cook Urological, Inc. | 2002-10-25 | Traditional | PDF ↗ |
| K013712 | ENTERYX INJECTOR | Enteric Medical Technologies | 2002-05-31 | Traditional | PDF ↗ |
| K012977 | VARICES INJECTION NEEDLE | Endo-Therapeutics, Inc. | 2001-11-02 | Traditional | PDF ↗ |
| K011484 | OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 | Olympus Optical Co., Ltd. | 2001-08-10 | Traditional | PDF ↗ |
| K010448 | HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES | Horizons Intl. Corp. | 2001-05-16 | Traditional | PDF ↗ |
| K002778 | ENTERIC INJECTION CATHETER WITH IRRIGATION | Enteric Medical Technologies, Inc. | 2000-11-22 | Traditional | PDF ↗ |
| K002573 | ADVANCED UROSCIENCE INNERSHEATH | Advanced Uroscience, Inc. | 2000-11-16 | Traditional | PDF ↗ |
| K002323 | ADVANCED UROSCIENCE INJECTION NEEDLE | Advanced Uroscience, Inc. | 2000-07-31 | Special | PDF ↗ |
| K001146 | GENYX FLEXIBLE INJECTION NEEEDLE | Geny Medical, Inc. | 2000-06-30 | Traditional | PDF ↗ |
| K000646 | DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE | Enteric Medical Technologies | 2000-04-13 | Traditional | PDF ↗ |
| K990996 | GENYX MEDICAL INJECTION NEEDLE | Genyx Medical, Inc. | 1999-06-18 | Traditional | PDF ↗ |
| K983765 | INJECTION NEEDLE PROBE/DEVICE-TUNIS | Ximed/Prosure/Injectx | 1998-12-11 | Traditional | PDF ↗ |
| K982890 | ADVANCED UROSCIENCE INJECTION NEEDLE | Advanced Uroscience, Inc. | 1998-10-26 | Traditional | PDF ↗ |
| K961846 | NEEDLE CATHETER | Boston Scientific Corp | 1996-07-15 | Traditional | PDF ↗ |
| K960519 | MARTECH ENDOSCOPIC INJECTION NEEDLE | Martech Medical Products, Inc. | 1996-05-01 | Traditional | PDF ↗ |
| K955558 | GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES | Medi-Globe Corp. | 1996-02-29 | Traditional | PDF ↗ |
| K954519 | WANG TRANSENDOSCOPIC ASPIRATION NEEDLE | Mill-Rose Laboratory | 1995-12-22 | Traditional | PDF ↗ |
| K953441 | RIZA-RIBE NEEDLE | R-Med, Inc. | 1995-08-18 | Traditional | PDF ↗ |
| K953338 | INJECTION NEEDLE | Boston Scientific Corp | 1995-08-02 | Traditional | PDF ↗ |
| K951648 | MIST ENDOSCOPIC NEEDLES | Mist, Inc. | 1995-05-12 | Traditional | PDF ↗ |
| K950976 | KARL STORZ ADULT AND PEDIATRIC VISCOUS FLUID INJECTION SETS | KARL STORZ Endoscopy-America, Inc. | 1995-03-21 | Traditional | PDF ↗ |
| K941305 | WILSON-COOK VARIABLE LENGTH GI INJECTION NEEDLE | Wilson-Cook Medical, Inc. | 1994-06-02 | Traditional | PDF ↗ |
| K933815 | BARD ENDOSCOPIC INJECTION SYSTEM | C.R. Bard, Inc. | 1993-12-01 | Traditional | PDF ↗ |
| K921800 | COLONOSCOPIC INJECTION NEEDLE, C-323/C-325 | Mill-Rose Laboratory | 1993-02-08 | Traditional | PDF ↗ |
| K924102 | NEEDLE | United States Endoscopy Group, Inc. | 1992-11-25 | Traditional | PDF ↗ |
| K914496 | SCLEROTHERAPY NEEDLE | Surgitek Medical Engineering Corp. | 1991-12-05 | Traditional | PDF ↗ |
| K903668 | WILSON-COOK ASPIRATION HANDLE | Wilson-Cook Medical, Inc. | 1990-10-15 | Traditional | PDF ↗ |
| K902736 | NM INJECTION NEEDLES | Olympus Corp. | 1990-08-24 | Traditional | PDF ↗ |
| K901437 | TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE | Telemed Systems, Inc. | 1990-06-18 | Traditional | PDF ↗ |
| K896424 | PORGES SCLEROTHERAPY NEEDLES | Porges Corp. | 1990-01-26 | Traditional | PDF ↗ |
| K894868 | WILTEK VARICES INJECTION NEEDLE | Wiltek Medical, Inc. | 1989-12-21 | Traditional | PDF ↗ |
| K883093 | TRANSENDOSCOPIC ASPIRATION NEEDLE | Endovations | 1988-12-08 | Traditional | PDF ↗ |
| K872060 | WASHING/INJECTION NEEDLE | Endovations | 1987-07-21 | Traditional | PDF ↗ |
| K865086 | WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE | Van-Tec, Inc. | 1987-03-10 | Traditional | PDF ↗ |
| K855176 | TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS | Urologic Surgical Devices Corp. | 1986-05-13 | Traditional | PDF ↗ |
| K851952 | VARICES INJECTOR | Wilson-Cook Medical, Inc. | 1985-07-26 | Traditional | PDF ↗ |
| K834403 | INJECTION NEEDLE | Bobbs Medical, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K820973 | ENDOSCOPIC INJECTION NEEDLE | Mill-Rose Laboratory | 1982-04-16 | Traditional | PDF ↗ |
| K812057 | VANCE CYSTOSCOPIC | Vance Products, Inc. | 1981-07-31 | Traditional | PDF ↗ |
Product code FBK · Class II · Gastroenterology, Urology. Data: openFDA.