Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use— 510(k) K192679

Name: FDA 510(k) clearance K192679
Creator: U.S. Food and Drug Administration
Published: 2020-04-10

Substantially Equivalent

Gemtier Medical (Shanghai), Inc.

FDA 510(k) clearance K192679 for Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Substantially Equivalent on 2020-04-10. 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: 2019-09-26
Decision date: 2020-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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More clearances from Gemtier Medical (Shanghai), Inc.

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K212652 — Sterile Syringe with Fixed Safety Needle for Single Use2022-03-02
K202493 — Medical Face Mask2021-02-04
K202331 — Medical Face Mask2021-02-02
K170276 — Safety Blood Collection Device for Single Use2017-12-11

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.