Galilei G6 Lens Professional
K-Number: K182659 · 2019-07-25
ApplicantSis Ag, Surgical Instrument Systems
Decision Date2019-07-25
Product CodeMXK
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
Galilei G6 Lens Professional is a medical device manufactured by Sis Ag, Surgical Instrument Systems. It received FDA 510(k) clearance on 2019-07-25 under approval number K182659. The device is classified under product code MXK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Galilei G6 Lens Professional?
Galilei G6 Lens Professional is a medical device that received FDA 510(k) clearance on 2019-07-25. It is manufactured by Sis Ag, Surgical Instrument Systems. The 510(k) number is K182659.
When was Galilei G6 Lens Professional approved by the FDA?
Galilei G6 Lens Professional received FDA 510(k) clearance on 2019-07-25, under approval number K182659.
What company makes Galilei G6 Lens Professional?
Galilei G6 Lens Professional is manufactured by Sis Ag, Surgical Instrument Systems.
What is the FDA product code for Galilei G6 Lens Professional?
The FDA product code for Galilei G6 Lens Professional is MXK.
Related Devices (Code: MXK)
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.