Cleared Traditional

Cary

K251111 · Excitus AS · General & Plastic Surgery
May 2025
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K251111 is an FDA 510(k) clearance for the Cary, a Apparatus, Suction, Ward Use, Portable, Ac-powered (Class II — Special Controls, product code JCX), submitted by Excitus AS (Stavanger, NO). The FDA issued a Cleared decision on May 7, 2025, 26 days after receiving the submission on April 11, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number K251111 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2025
Decision Date May 07, 2025
Days to Decision 26 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code JCX — Apparatus, Suction, Ward Use, Portable, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4780

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