Cary— 510(k) K251111

Name: FDA 510(k) clearance K251111
Creator: U.S. Food and Drug Administration
Published: 2025-05-07

Substantially Equivalent

Excitus AS

FDA 510(k) clearance K251111 for Cary, Substantially Equivalent on 2025-05-07. Applicant: Excitus AS. Device class: 2.

Clearance details

Applicant: Excitus AS
Product code: Code JCX
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 2025-04-11
Decision date: 2025-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stavanger, NO

Download summary PDF View on FDA.gov ↗

Recent devices under product code JCX

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K250964 — Protable Phlegm Suction Unit (JMA D01)2026-05-11
K243638 — MV Flow Aspiration Pump (MVFLOWPMP01)2025-06-13
K243418 — Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing2024-12-02
K233428 — Easycess Aspiration Pump2023-11-03
K222552 — 120V Neptune S Rover (0711-001-000) +3 more2022-12-09

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.