Disposable Injection Needle AF series
FDA 510(k) K230925 · Alton (Shanghai) Medical Instruments Co., Ltd.
510(k) numberK230925
Submission
- Device name
- Disposable Injection Needle AF series
- Applicant
- Alton (Shanghai) Medical Instruments Co., Ltd.
Shanghai, CN - Received
- April 3, 2023
- Decision date
- September 27, 2023
- 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 |
|---|---|---|
| K243039 | Ureteral Stents (AF-D series)FAD · Traditional | 06/18/2025SE |
| K242635 | Endoscopic Distal Attachment (AF-D series)FDS · Traditional | 05/30/2025SE |
| K241679 | Disposable Cytology Brush (AF series)KTI · Traditional | 03/04/2025SE |
| K241285 | Disposable Endoscope Valves Set (AF series)ODC · Traditional | 10/01/2024SE |
| K231633 | Disposable Hemoclip (AF series)PKL · Traditional | 01/11/2024SE |
Questions and answers
When was Disposable Injection Needle AF series cleared by the FDA?
Disposable Injection Needle AF series (K230925) received a 510(k) decision of Substantially Equivalent on September 27, 2023, 177 days after the submission was received.
What is the product code of K230925?
The FDA product code is FBK – Endoscopic Injection Needle, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.