Martech Endoscopic Injection Needle
FDA 510(k) K960519 · Martech Medical Products, Inc.
510(k) numberK960519
Submission
- Device name
- Martech Endoscopic Injection Needle
- Applicant
- Martech Medical Products, Inc.
Harleysville, PA, US - Received
- February 5, 1996
- Decision date
- May 1, 1996
- 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.
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|---|---|---|---|
| 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 |
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| K130855 | PTFE Super Sheath IntroducerDYB · Traditional | 07/29/2013SE |
| K120617 | PTFE Super Sheath IntroducerDYB · Traditional | 11/19/2012SE |
| K101399 | Coaxial Introducer SetDYB · Traditional | 06/17/2010SE |
| K931924 | Marksman Arterial Blood Gas SyringeJKA · Traditional | 08/03/1993SE |
| K922438 | PRO2 Oxygen AnalyzerCCL · Traditional | 03/05/1993SE |
| K926007 | Accessory to Piston SyringeFMF · Traditional | 02/23/1993SE |
| K914778 | Neoline(Tm)CBT · Traditional | 09/16/1992SESK |
| K910970 | Marksman Arterial Blood Gas SyringeJKA · Traditional | 10/15/1991SE |
| K890473 | Needle Guard(Tm)FMI · Traditional | 04/03/1989SE |
Questions and answers
When was Martech Endoscopic Injection Needle cleared by the FDA?
Martech Endoscopic Injection Needle (K960519) received a 510(k) decision of Substantially Equivalent on May 1, 1996, 86 days after the submission was received.
What is the product code of K960519?
The FDA product code is FBK – Endoscopic Injection Needle, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.