FBK
- Product code
- FBK
- Device name
- Endoscopic Injection Needle, Gastroenterology-Urology
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 11
- Summaries archived here
- 10 (direct download)
- 510(k) clearances (all years, FDA)
- 89 (all years; only the last 3 years are listed here)
FDA classification definition
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
510(k) clearances, last 3 years (11)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260262 | 2026-05-29 | Mirco-Tech (Nanjing) Co., Ltd. | Injection Needle | |
| K253598 | 2026-03-31 | Carbon Medical Technologies, Inc. | InjecSURE Injection System | FDA |
| K252021 | 2025-12-02 | Changzhou New Med Micro-Medtech Co., L… | Disposable Endoscopic Injection Needles | |
| K252247 | 2025-10-16 | Olympus Medical Systems Corporation | Injector Force Max Single Use Injector (NM-400L); In… | |
| K241595 | 2025-02-27 | Veol Medical Technologies Pvt , Ltd. | EzVu Visual Vasopressor injector (EV-19) | |
| K240675 | 2024-10-04 | Promisemed Hangzhou Meditech Co., Ltd. | Endoscopic Injection Needles | |
| K241523 | 2024-08-27 | Laborie Medical Technologies, Corp. | injeTAK Adjustable Tip Needle (DIS199; DIS201) | |
| K232200 | 2024-04-12 | Ningbo Xinwell Medical Technology Co.,… | Disposable Injection Needles | |
| K232826 | 2024-03-08 | Steris | Articulator Injection Needle (00711807), Articulator… | |
| K232442 | 2023-11-09 | Zhejiang Soudon Medical Technology Co.… | Disposable Endoscope Injection Needles | |
| K230925 | 2023-09-27 | Alton (Shanghai) Medical Instruments C… | Disposable Injection Needle AF series |
Official FDA classification page: FBK
Classification and pathway per current FDA publications. Data from openFDA (CC0).