1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle— 510(k) K192551

Name: FDA 510(k) clearance K192551
Creator: U.S. Food and Drug Administration
Published: 2020-08-10

Substantially Equivalent

Jiangsu Caina Medical Co.,Ltd

FDA 510(k) clearance K192551 for 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle, Substantially Equivalent on 2020-08-10. Applicant: Jiangsu Caina Medical Co.,Ltd. Device class: 2.

Clearance details

Applicant: Jiangsu Caina Medical Co.,Ltd
Product code: Code MEG
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2019-09-17
Decision date: 2020-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiangyin, CN

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.