Acare Suction Unit— 510(k) K182950

Name: FDA 510(k) clearance K182950
Creator: U.S. Food and Drug Administration
Published: 2019-08-23

Substantially Equivalent

Acare Technology Co., Ltd.

FDA 510(k) clearance K182950 for Acare Suction Unit, Substantially Equivalent on 2019-08-23. Applicant: Acare Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Acare Technology Co., Ltd.
Product code: Code JCX
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 2018-10-23
Decision date: 2019-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

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.