Sterile Syringe with Fixed Safety Needle for Single Use— 510(k) K212652

Substantially Equivalent

Gemtier Medical (Shanghai), Inc.

FDA 510(k) clearance K212652 for Sterile Syringe with Fixed Safety Needle for Single Use, Substantially Equivalent on 2022-03-02. Applicant: Gemtier Medical (Shanghai), Inc..

Clearance details

Applicant: Gemtier Medical (Shanghai), Inc.
Product code: Code MEG
Advisory panel: General Hospital
Date received: 2021-08-23
Decision date: 2022-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code MEG

product code MEG

Malfunction: 1,373
Other: 1
Total: 1,374

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.