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Disposable Endoscopic Injection Needles

by Changzhou New Med Micro-Medtech Co., Ltd.

510(k) K252021

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK252021 Date2 Dec 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FBK
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Disposable Endoscopic Injection Needles are endoscopic injection needles intended for use with a flexible endoscope to aid physicians in performing endoscopic injection for submucosal injection in the digestive tract. The device is classified as a Class 2 medical device under the Gastroenterology and Urology specialties.

The device is supplied as a single-use, sterile product and is manufactured by Changzhou New Med Micro-Medtech Co., Ltd. It received FDA 510(k) clearance (K252021) via the Traditional pathway on December 2, 2025, and is identified by product code FBK and regulation number 876.1500.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of Disposable Endoscopic Injection Needles?

    Disposable Endoscopic Injection Needles are intended for use with a flexible endoscope to aid physicians in performing endoscopic injection for submucosal injection in the digestive tract. This allows for precise delivery of agents beneath the mucosal layer during gastrointestinal procedures.

  • How are Disposable Endoscopic Injection Needles supplied and sterilized?

    The device is supplied as a single-use, sterile product. It is manufactured in a sterile condition and intended for one-time use only to prevent cross-contamination and ensure patient safety during endoscopic procedures.

  • What regulatory pathway and clearance apply to Disposable Endoscopic Injection Needles?

    Disposable Endoscopic Injection Needles received FDA 510(k) clearance via the Traditional pathway under clearance number K252021, granted on December 2, 2025. The device is classified as Class 2 and identified by product code FBK and regulation number 876.1500.