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

Name: FDA 510(k) clearance K212652
Creator: U.S. Food and Drug Administration
Published: 2022-03-02

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.. Device class: 2.

Clearance details

Applicant: Gemtier Medical (Shanghai), Inc.
Product code: Code MEG
Device class: Class 2
Regulation: 21 CFR 880.5860
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 ↗

Recent devices under product code MEG

view all

K252098 — PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)2026-02-18
K250847 — VaporShield2025-12-12
K230287 — SaviSafe Safety Device2023-11-21
K231165 — Shina Syringe; Shina Safety Syringe2023-10-27
K231907 — Medline Safety Insulin and TB Syringes2023-10-18

More clearances from Gemtier Medical (Shanghai), Inc.

view all

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.