3S Safety Syringe with/without Needle— 510(k) K142435

Name: FDA 510(k) clearance K142435
Creator: U.S. Food and Drug Administration
Published: 2015-02-20

Substantially Equivalent

Sincere Medical Device Co., Ltd.

FDA 510(k) clearance K142435 for 3S Safety Syringe with/without Needle, Substantially Equivalent on 2015-02-20. Applicant: Sincere Medical Device Co., Ltd.. Device class: 2.

Clearance details

Applicant: Sincere Medical Device Co., Ltd.
Product code: Code MEG
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2014-08-29
Decision date: 2015-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

Download summary PDF View on FDA.gov ↗

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K142436 — 3S Safety Insulin Syringe2015-02-19

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.