Injection Needle
FDA 510(k) K132065 · Endochoice, Inc.
510(k) numberK132065
Submission
- Device name
- Injection Needle
- Applicant
- Endochoice, Inc.
Alpharetta, GA, US - Received
- July 3, 2013
- Decision date
- January 17, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FBK – Endoscopic Injection Needle, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
Other 510(k)s with product code FBK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260262 | Injection NeedleFBK · Traditional | Mirco-Tech (Nanjing) Co., Ltd. | 05/29/2026SE |
| K253598 | InjecSURE Injection SystemFBK · Traditional | Carbon Medical Technologies, Inc. | 03/31/2026SE |
| K252021 | Disposable Endoscopic Injection NeedlesFBK · Traditional | Changzhou New Med Micro-Medtech Co., Ltd. | 12/02/2025SE |
| K252247 | Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector…FBK · Traditional | Olympus Medical Systems Corporation | 10/16/2025SE |
| K241595 | EzVu Visual Vasopressor injector (EV-19)FBK · Traditional | Veol Medical Technologies Pvt , Ltd. | 02/27/2025SE |
| K240675 | Endoscopic Injection NeedlesFBK · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 10/04/2024SE |
| K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201)FBK · Special | Laborie Medical Technologies, Corp. | 08/27/2024SE |
| K232200 | Disposable Injection NeedlesFBK · Traditional | Ningbo Xinwell Medical Technology Co., Ltd. | 04/12/2024SE |
| K232826 | Articulator Injection Needle (00711807), Articulator Injection Needle (00711810)…FBK · Traditional | Steris | 03/08/2024SE |
| K232442 | Disposable Endoscope Injection NeedlesFBK · Traditional | Zhejiang Soudon Medical Technology Co., Ltd. | 11/09/2023SE |
More from Zhejiang Soudon Medical Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K160275 | Fuse Endoscopic System with FuseBox ProcessorPEA · Traditional | 08/01/2016SE |
| K161482 | EndoChoice Water Bottle Cap Irrigation SystemFEQ · Special | 06/27/2016SE |
| K161167 | Seal Single-Use Biopsy ValveOCX · Special | 05/26/2016SE |
| K160403 | SmartStart Air/Water and Suction ValvesODC · Traditional | 05/19/2016SE |
| K153588 | EndoChoice Water Bottle Cap SystemFEQ · Special | 02/24/2016SE |
| K151475 | EndoChoice Select Injection NeedleFBK · Traditional | 02/08/2016SE |
| K152182 | Fuse Gastroscopy SystemFDS · Special | 12/10/2015SE |
| K152580 | rescuenetFDI · Traditional | 11/03/2015SE |
| K142155 | Endochoice Water Bottle Cap SystemFEQ · Traditional | 01/20/2015SE |
| K140472 | Bonastent Tracheal / BronchialJCT · Traditional | 10/17/2014SE |
Questions and answers
When was Injection Needle cleared by the FDA?
Injection Needle (K132065) received a 510(k) decision of Substantially Equivalent on January 17, 2014, 198 days after the submission was received.
What is the product code of K132065?
The FDA product code is FBK – Endoscopic Injection Needle, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.