Identifiers
- 510(k) Number
- K150434 FDA 510(k)
- FDA Product Code
- FBK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Injection Needle is a medical device used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varices and for submucosal dye marking in the GI tract. It is designed for single-handed operation and is offered in 22 and 25 gauge, with lengths of 3 mm and 5 mm.
The device is supplied as a disposable injection needle and is intended for use in gastroenterology and urology. It has a product code of FBK and a regulation number of 876.1500, with authorizations including FDA 510K clearance. The device is manufactured by Micro-Tech (Nanjing) Co., Ltd.
Frequently asked questions
What is the Injection Needle used for?
The Injection Needle is used for endoscopic injections, such as treating esophageal and gastric varices and submucosal dye marking in the GI tract.
Is the Injection Needle reusable?
The Injection Needle is supplied as a disposable device, intended for single-use.
What sizes are available for the Injection Needle?
The Injection Needle is offered in 22 and 25 gauge, with lengths of 3 mm and 5 mm.
What medical specialties use the Injection Needle?
The Injection Needle is intended for use in gastroenterology and urology.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MICRO-TECH | Innovative Endoscopic & Medical Device Solutions, Injection Needles | Micro-Tech Endoscopy, Injection Needle by Micro-Tech (Nanjing) CO., Ltd. | FDA 510 (k) Summary, Injection Needles - MICRO-TECH EUROPE
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150434 | Class II | Active |
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Manufacturer
- Manufacturer
- Micro-Tech (Nanjing) Co., Ltd.
Sources (1)
- FDA 510(k) K150434 24 fields · synced Sep 24, 2026