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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

Disposable Endoscopic Injection Needles

Manufacturer

Changzhou New Med Micro-Medtech Co., Ltd.

Date Cleared

2025-12-02

(155 days)

Product Code

Regulation Number

Type

Panel

Gastroenterology/Urology

Age Range

All

Reference & Predicate Devices

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

This product is intended to be used in conjunction with an endoscope for the submucosal injection in the digestive tract.

Device Description

The Disposable Endoscopic Injection Needle is intended to be used in conjunction with an endoscope for the submucosal injection in the digestive tract.

This device consists of the handle assembly, inner and outer tubes, introducer, and needle tip assembly.

The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.

AI/ML Overview

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