IRIS 1.0 System
K-Number: K182643 · 2019-02-22
ApplicantIntuitive Surgical
Decision Date2019-02-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
IRIS 1.0 System is a medical device manufactured by Intuitive Surgical. It received FDA 510(k) clearance on 2019-02-22 under approval number K182643. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IRIS 1.0 System?
IRIS 1.0 System is a medical device that received FDA 510(k) clearance on 2019-02-22. It is manufactured by Intuitive Surgical. The 510(k) number is K182643.
When was IRIS 1.0 System approved by the FDA?
IRIS 1.0 System received FDA 510(k) clearance on 2019-02-22, under approval number K182643.
What company makes IRIS 1.0 System?
IRIS 1.0 System is manufactured by Intuitive Surgical.
What is the FDA product code for IRIS 1.0 System?
The FDA product code for IRIS 1.0 System is LLZ.
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Related Devices (Code: LLZ)
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.