Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IntelliCartTM System

K-Number: K190789 · 2019-04-24

ApplicantDornoch Medical Systems
Decision Date2019-04-24
Product CodeJCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IntelliCartTM System is a medical device manufactured by Dornoch Medical Systems. It received FDA 510(k) clearance on 2019-04-24 under approval number K190789. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IntelliCartTM System?

IntelliCartTM System is a medical device that received FDA 510(k) clearance on 2019-04-24. It is manufactured by Dornoch Medical Systems. The 510(k) number is K190789.

When was IntelliCartTM System approved by the FDA?

IntelliCartTM System received FDA 510(k) clearance on 2019-04-24, under approval number K190789.

What company makes IntelliCartTM System?

IntelliCartTM System is manufactured by Dornoch Medical Systems.

What is the FDA product code for IntelliCartTM System?

The FDA product code for IntelliCartTM System is JCX.

Other Devices by Dornoch Medical Systems

K162421IntelliCartTM System K172481IntelliCart System

Related Devices (Code: JCX)

K162421IntelliCartTM SystemDornoch Medical Systems K153407Stryker Neptune 3 Waste Management SystemStryker Corporation K172481IntelliCart SystemDornoch Medical Systems K161358Medline ReNewal Reprocessed Stryker Neptune 2 ManifoldsSurgical Instrument Service and Savings, Inc. K180115TWBM PumpTaiwan Biomaterial Co., Ltd. K181398DV-300 AspiratorDing Hwa Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑