FBK — Endoscopic Injection Needle, Gastroenterology-Urology Class II
FDA product code FBK covers "Endoscopic Injection Needle, Gastroenterology-Urology", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260262 | mirco-tech (nanjing) co | Injection Needle | May 29, 2026 |
| K253598 | carbon medical technologies | InjecSURE Injection System | March 31, 2026 |
| 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 |