AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE— 510(k) K121637

Name: FDA 510(k) clearance K121637
Creator: U.S. Food and Drug Administration
Published: 2012-10-25

Substantially Equivalent

Sunwell Biotech Co., Ltd.

FDA 510(k) clearance K121637 for AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE, Substantially Equivalent on 2012-10-25. Applicant: Sunwell Biotech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Sunwell Biotech Co., Ltd.
Product code: Code MEG
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2012-06-04
Decision date: 2012-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Echo, OR, US

Download summary PDF View on FDA.gov ↗

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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.