FBK — Endoscopic Injection Needle, Gastroenterology-Urology Class II
Classification Details
- Product Code
- FBK
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252021 | changzhou new med micro-medtech co | Disposable Endoscopic Injection Needles | December 2, 2025 |
| K252247 | olympus medical systems corporation | Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use | October 16, 2025 |
| K241595 | veol medical technologies pvt | EzVu Visual Vasopressor injector (EV-19) | February 27, 2025 |
| K240675 | promisemed hangzhou meditech co | Endoscopic Injection Needles | October 4, 2024 |
| K241523 | laborie medical technologies | injeTAK Adjustable Tip Needle (DIS199; DIS201) | August 27, 2024 |
| K232200 | ningbo xinwell medical technology co | Disposable Injection Needles | April 12, 2024 |
| K232826 | steris | Articulator Injection Needle (00711807), Articulator Injection Needle (00711810) | March 8, 2024 |
| K232442 | zhejiang soudon medical technology co | Disposable Endoscope Injection Needles | November 9, 2023 |
| K230925 | alton (shanghai) medical instruments co | Disposable Injection Needle AF series | September 27, 2023 |
| K222006 | g-flex europe sprl | Sclerotherapy & Endoscopic Needles | April 3, 2023 |
| K221054 | incore co | CORE-INJECTOR | December 21, 2022 |
| K221085 | lina medical aps | LiNA OperaScope Needle | September 2, 2022 |
| K220292 | yangzhou fartley medical instrument technology co | Disposable Endoscope Injection Needle | August 19, 2022 |
| K213914 | jiangsu vedkang medical science and technology co | Injection Needle | July 29, 2022 |
| K213239 | beijing zksk technology co | Endoscopic Injection Needle | June 2, 2022 |
| K212668 | zhejiang chuangxiang medical technology co | Sclerotherapy Needle | February 23, 2022 |
| K210917 | anrei medical (hangzhou) co | Single Use Injection Needle | May 28, 2021 |
| K192498 | olympus medical systems | Single Use Injector | April 28, 2020 |
| K190032 | hangzhou ags medtech co | Disposable Sclerotherapy Needle | February 27, 2020 |
| K190829 | wilson-cook medical inc./cook endoscopy | Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) | December 19, 2019 |