Injection Needle
FDA 510(k) K150434 · Micro-Tech (Nanjing) Co., Ltd.
510(k) numberK150434
Submission
- Device name
- Injection Needle
- Applicant
- Micro-Tech (Nanjing) Co., Ltd.
Nanjing, CN - Received
- February 19, 2015
- Decision date
- June 2, 2015
- 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 |
|---|---|---|
| K252492 | Visualized Access and Delivery Catheter; PB Digital ControllerSHU · Traditional | 04/24/2026SE |
| K251692 | Advanced Tissue Resection DeviceFDI · Traditional | 02/21/2026SE |
| K250229 | Dual Action Tissue Closure DevicePKL · Traditional | 09/08/2025SE |
| K243388 | Disposable Distal CapFDS · Traditional | 06/27/2025SE |
| K243471 | Extraction BasketLQR · Traditional | 12/16/2024SE |
| K230127 | Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set…FGE · Traditional | 09/06/2023SE |
| K221784 | Single-use Video Pancreaticobiliary Scope, PB Digital ControllerFBN · Traditional | 02/16/2023SE |
| K222354 | Elastic Traction SystemQSW · Traditional | 10/03/2022SE |
| K213060 | AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…KTI · Traditional | 07/20/2022SE |
| K220424 | Through the Scope Tracheal Stent SystemJCT · Traditional | 07/08/2022SE |
Questions and answers
When was Injection Needle cleared by the FDA?
Injection Needle (K150434) received a 510(k) decision of Substantially Equivalent on June 2, 2015, 103 days after the submission was received.
What is the product code of K150434?
The FDA product code is FBK – Endoscopic Injection Needle, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.