Cary

FDA 510(k) K251111 · Excitus AS

Substantially Equivalent

510(k) numberK251111

Submission

Device name
Cary
Applicant
Excitus AS
Stavanger, NO
Received
April 11, 2025
Decision date
May 7, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4780
Specialty
General, Plastic Surgery

Other 510(k)s with product code JCX

510(k)DeviceApplicantDecision
K250964Protable Phlegm Suction Unit (JMA D01)JCX · Traditional Jiangsu Jumao X-Care Medical Equipment Co., Ltd.05/11/2026SE
K243638MV Flow Aspiration Pump (MVFLOWPMP01)JCX · Traditional Microvention06/13/2025SE
K243418Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate TubingJCX · Special Micro Therapeutics, Inc. d/b/a ev3 Neurovascular12/02/2024SE
K233428Easycess Aspiration PumpJCX · Traditional Guangzhou Easycess Medical Co.,Ltd11/03/2023SE
K222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen…JCX · Traditional Stryker Instruments12/09/2022SE
K182950Acare Suction UnitJCX · Traditional Acare Technology Co., Ltd.08/23/2019SE
K190789IntelliCartTM SystemJCX · Special Dornoch Medical Systems04/24/2019SE
K190105ZOOM Aspiration PumpJCX · Special Taiwan Biomaterial Co., Ltd.02/21/2019SE
K180115TWBM PumpJCX · Traditional Taiwan Biomaterial Co., Ltd.07/24/2018SE
K181398DV-300 AspiratorJCX · Traditional Ding Hwa Co., Ltd.07/23/2018SE

Questions and answers

When was Cary cleared by the FDA?

Cary (K251111) received a 510(k) decision of Substantially Equivalent on May 7, 2025, 26 days after the submission was received.

What is the product code of K251111?

The FDA product code is JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 878.4780.