CARE SU01A SUCTION ASPIRATOR— 510(k) K130001

Name: FDA 510(k) clearance K130001
Creator: U.S. Food and Drug Administration
Published: 2013-07-25

Substantially Equivalent

Foshan Care Medical Technology Co., Ltd.

FDA 510(k) clearance K130001 for CARE SU01A SUCTION ASPIRATOR, Substantially Equivalent on 2013-07-25. Applicant: Foshan Care Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Foshan Care Medical Technology Co., Ltd.
Product code: Code JCX
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 2013-01-02
Decision date: 2013-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foshan, Guangdong, CN

Download summary PDF View on FDA.gov ↗

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K243418 — Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing2024-12-02
K233428 — Easycess Aspiration Pump2023-11-03

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Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.