FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Enteric Medical Technologies Enteryx™ Injector Disposable Endoscopic Injection Catheter is to be 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 upper GI tract.

Device Description

Enteryx™ Injector Disposable Endoscopic Injection Catheter

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria, device performance, sample sizes, expert qualifications, or study details for the Enteryx™ Injection Catheter. The document is a 510(k) premarket notification letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters and intended use, but not the specific technical performance or study results.

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K Number

K002778

Device Name

ENTERIC INJECTION CATHETER WITH IRRIGATION

Manufacturer

ENTERIC MEDICAL TECHNOLOGIES, INC.

Date Cleared

2000-11-22

(77 days)

Product Code