injeTAK Adjustable Tip Needle (DIS199; DIS201)
FDA 510(k) K241523 · Laborie Medical Technologies, Corp.
510(k) numberK241523
Submission
- Device name
- injeTAK Adjustable Tip Needle (DIS199; DIS201)
- Applicant
- Laborie Medical Technologies, Corp.
Portsmouth, NH, US - Received
- May 29, 2024
- Decision date
- August 27, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
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| K090830 | Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipFBK · Traditional | 07/21/2009SE |
| K082614 | Evox Electro Diagnostic DeviceGWF · Traditional | 03/06/2009SE |
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| K073552 | Laborie Urodynamic System with Tetra AccessoryFEN · Traditional | 03/05/2008SE |
| K070331 | Urostym Biofeedback and Stimulation Device and AccessoriesKPI · Traditional | 05/04/2007SE |
| K962009 | UrostymKPI · Traditional | 05/20/1997SE |
| K955856 | Tex-Aid BlueLKY · Traditional | 02/16/1996SE |
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Questions and answers
When was injeTAK Adjustable Tip Needle (DIS199; DIS201) cleared by the FDA?
injeTAK Adjustable Tip Needle (DIS199; DIS201) (K241523) received a 510(k) decision of Substantially Equivalent on August 27, 2024, 90 days after the submission was received.
What is the product code of K241523?
The FDA product code is FBK – Endoscopic Injection Needle, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.