IntelliCartTM System
K-Number: K162421 · 2016-12-21
ApplicantDornoch Medical Systems
Decision Date2016-12-21
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 2016-12-21 under approval number K162421. 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 2016-12-21. It is manufactured by Dornoch Medical Systems. The 510(k) number is K162421.
When was IntelliCartTM System approved by the FDA?
IntelliCartTM System received FDA 510(k) clearance on 2016-12-21, under approval number K162421.
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
Related Devices (Code: JCX)
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.
K182950Acare Suction UnitAcare Technology 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.