Plastic LOR Syringe— 510(k) K201356

Name: FDA 510(k) clearance K201356
Creator: U.S. Food and Drug Administration
Published: 2021-02-12

Substantially Equivalent

Jiangsu Caina Medical Co.,Ltd

FDA 510(k) clearance K201356 for Plastic LOR Syringe, Substantially Equivalent on 2021-02-12. Applicant: Jiangsu Caina Medical Co.,Ltd. Device class: 2.

Clearance details

Applicant: Jiangsu Caina Medical Co.,Ltd
Product code: Code CAZ
Device class: Class 2
Regulation: 21 CFR 868.5140
Advisory panel: Anesthesiology
Date received: 2020-05-21
Decision date: 2021-02-12
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 CAZ

product code CAZ

Injury: 145
Malfunction: 942
Other: 1
Total: 1,088

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.