510(k) K252021— Disposable Endoscopic Injection Needles

Substantially Equivalent

Changzhou New Med Micro-Medtech Co., Ltd.

Clearance details

Applicant: Changzhou New Med Micro-Medtech Co., Ltd.
Product code: Code FBK
Advisory panel: Gastroenterology, Urology
Date received: 2025-06-30
Decision date: 2025-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, CN

Adverse events under product code FBK

product code FBK

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.