Endoscopic Injection Needles
FDA 510(k) K240675 · Promisemed Hangzhou Meditech Co., Ltd.
510(k) numberK240675
Submission
- Device name
- Endoscopic Injection Needles
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd.
Hangzhou City, CN - Received
- March 11, 2024
- Decision date
- October 4, 2024
- 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 |
| 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 |
| K230925 | Disposable Injection Needle AF seriesFBK · Traditional | Alton (Shanghai) Medical Instruments Co., Ltd. | 09/27/2023SE |
More from Alton (Shanghai) Medical Instruments Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261719 | Promisemed X-Safety Pen NeedleFMI · Special | 08/25/2026SE |
| K261196 | Promisemed VeriEcto Automatic Biopsy NeedlesKNW · Special | 05/12/2026SE |
| K261045 | Verifine Safety LancetsFMK · Special | 05/01/2026SE |
| K254273 | Verisafe Safety Sterile Needles (SSN)FMI · Special | 04/16/2026SE |
| K250192 | Verisafe Safety Retractable Insulin SyringesFMF · Traditional | 12/10/2025SE |
| K250961 | Blood collection tube holdersJKA · Traditional | 06/04/2025SE |
| K251138 | Promisemed Safety Huber NeedlesPTI · Special | 05/13/2025SE |
| K243332 | Promisemed Safety Huber NeedlesPTI · Special | 03/14/2025SE |
| K243806 | Safety Winged Blood Collection SetsFMI · Special | 01/10/2025SE |
| K242632 | Verifine® Pen NeedlesFMI · Special | 09/26/2024SE |
Questions and answers
When was Endoscopic Injection Needles cleared by the FDA?
Endoscopic Injection Needles (K240675) received a 510(k) decision of Substantially Equivalent on October 4, 2024, 207 days after the submission was received.
What is the product code of K240675?
The FDA product code is FBK – Endoscopic Injection Needle, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.