Product code FBK
- Device name
- Endoscopic Injection Needle, Gastroenterology-Urology
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253598 | InjecSURE Injection System | Carbon Medical Technologies, Inc. | 2026-03-31 |
| K252021 | Disposable Endoscopic Injection Needles | Changzhou New Med Micro-Medtech Co., Ltd. | 2025-12-02 |
| 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 |
| K241595 | EzVu Visual Vasopressor injector (EV-19) | Veol Medical Technologies Pvt , Ltd. | 2025-02-27 |
| K240675 | Endoscopic Injection Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2024-10-04 |
| K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201) | Laborie Medical Technologies, Corp. | 2024-08-27 |
| K232200 | Disposable Injection Needles | Ningbo Xinwell Medical Technology Co., Ltd. | 2024-04-12 |
| 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... | Steris | 2024-03-08 |
| K232442 | Disposable Endoscope Injection Needles | Zhejiang Soudon Medical Technology Co., Ltd. | 2023-11-09 |
| K230925 | Disposable Injection Needle AF series | Alton (Shanghai) Medical Instruments Co., Ltd. | 2023-09-27 |
| K222006 | Sclerotherapy & Endoscopic Needles | G-Flex Europe Sprl | 2023-04-03 |
| K221054 | CORE-INJECTOR | Incore Co., Ltd. | 2022-12-21 |
| K221085 | LiNA OperaScope Needle | Lina Medical Aps | 2022-09-02 |
| K220292 | Disposable Endoscope Injection Needle | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-08-19 |
| K213914 | Injection Needle | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2022-07-29 |
| K213239 | Endoscopic Injection Needle | Beijing Zksk Technology Co., Ltd. | 2022-06-02 |
| K212668 | Sclerotherapy Needle | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022-02-23 |
| K210917 | Single Use Injection Needle | Anrei Medical (Hangzhou) Co., Ltd. | 2021-05-28 |
| K192498 | Single Use Injector | Olympus Medical Systems Corp. | 2020-04-28 |
| K190032 | Disposable Sclerotherapy Needle | Hangzhou AGS MedTech Co., Ltd. | 2020-02-27 |
| K190829 | Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) | Wilson-Cook Medical Inc./Cook Endoscopy | 2019-12-19 |
| K181690 | Clear-Jet Injection Catheter | Finemedix Co., Ltd. | 2018-12-21 |
| K180214 | Repris Bladder Injection System | Uro-1, Inc. | 2018-05-03 |
| K172227 | Endoscopic Injection Needle | Carbon Medical Technologies, Inc. | 2017-08-23 |
| K171602 | Williams Cystoscopic Injection Needle | Cook Incorporated | 2017-07-28 |
| K171454 | Interject Injection Therapy Needle Catheter | Boston Scientific Corporation | 2017-07-07 |
| K153625 | Single Use Injector NM600/610 | Olympus Medical Systems Corp. | 2016-02-12 |
| K151475 | EndoChoice Select Injection Needle | Endochoice, Inc. | 2016-02-08 |
| K152035 | iSnare system-Lariat | United States Endoscopy Group, Inc. | 2015-10-15 |
| K150434 | Injection Needle | Micro-Tech (Nanjing) Co., Ltd. | 2015-06-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10850002461425 | InjecSURE ® | Carbon Medical Technologies, Inc. | 2026-04-09 |
| 10850002461418 | InjecSURE ® | Carbon Medical Technologies, Inc. | 2026-04-09 |
| 10850002461395 | InjecSURE ® | Carbon Medical Technologies, Inc. | 2026-04-09 |
| 10850002461388 | InjecSURE ® | Carbon Medical Technologies, Inc. | 2026-04-09 |
| 08809327350667 | Clear-Jet Injection Catheter | FINEMEDIX CO.,LTD. | 2019-04-12 |
| 08809327350674 | Clear-Jet Injection Catheter | FINEMEDIX CO.,LTD. | 2019-04-12 |
| 08809327352388 | Clear-Jet Injection Catheter | FINEMEDIX CO.,LTD. | 2019-04-12 |
| 08809327352395 | Clear-Jet Injection Catheter | FINEMEDIX CO.,LTD. | 2019-04-12 |
| 08809327352401 | Clear-Jet Injection Catheter | FINEMEDIX CO.,LTD. | 2019-04-12 |
| 08809327352418 | Clear-Jet Injection Catheter | FINEMEDIX CO.,LTD. | 2019-04-12 |
| 08809327352425 | Clear-Jet Injection Catheter | FINEMEDIX CO.,LTD. | 2019-04-12 |
| 08714729745242 | Optiflo | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729745235 | Optiflo | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 10801334001551 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-09-23 |
| 10801334007416 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-09-23 |
| 08717591240280 | Rigid Endoscopic Needle | Uroplasty, Inc. | 2016-09-22 |
| 08717591240273 | Rigid Endoscopic Needle | Uroplasty, Inc. | 2016-09-22 |
| M84947210 | Hobbs Posi-Stop Injection Needle | HOBBS MEDICAL, INC. | 2016-09-21 |
| M84947200 | Hobbs Posi-Stop Injection Needle | HOBBS MEDICAL, INC. | 2016-09-21 |
| M84947180 | Hobbs Posi-Stop Injection Needle | HOBBS MEDICAL, INC. | 2016-09-21 |
| M84947160 | Hobbs Posi-Stop Injection Needle | HOBBS MEDICAL, INC. | 2016-09-21 |
| M8494714S0 | Hobbs Posi-Stop Injection Needle | HOBBS MEDICAL, INC. | 2016-09-21 |
| M84947140 | Hobbs Posi-Stop Injection Needle | HOBBS MEDICAL, INC. | 2016-09-21 |
| M84947120 | Hobbs Posi-Stop Injection Needle | HOBBS MEDICAL, INC. | 2016-09-21 |
| M84947080 | Hobbs Posi-Stop Injection Needle | HOBBS MEDICAL, INC. | 2016-09-21 |
| M84947060 | Hobbs Posi-Stop Injection Needle | HOBBS MEDICAL, INC. | 2016-09-21 |
| M84947040 | Hobbs Posi-Stop Injection Needle | HOBBS MEDICAL, INC. | 2016-09-21 |
| M84947020 | Hobbs Posi-Stop Injection Needle | HOBBS MEDICAL, INC. | 2016-09-21 |
| 10680651927702 | Halyard | Avanos Medical, Inc. | 2016-07-06 |
| 10680651927719 | Halyard | Avanos Medical, Inc. | 2016-07-06 |