Syringe with safety needle, Safety needle— 510(k) K193526

Name: FDA 510(k) clearance K193526
Creator: U.S. Food and Drug Administration
Published: 2020-07-17

Substantially Equivalent

Jiangsu Caina Medical Co.,Ltd

FDA 510(k) clearance K193526 for Syringe with safety needle, Safety needle, Substantially Equivalent on 2020-07-17. Applicant: Jiangsu Caina Medical Co.,Ltd. Device class: 2.

Clearance details

Applicant: Jiangsu Caina Medical Co.,Ltd
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2019-12-19
Decision date: 2020-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiangyin, CN

Download summary PDF View on FDA.gov ↗

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K233190 — ENFit Adaptor2024-01-18
K230635 — Pen Needle2023-06-02
K222834 — Safety Push Button Blood Collection Set2023-01-05
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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.