MAXReach Laser Probe
K-Number: K191846 · 2019-12-23
ApplicantVortex Surgical, Inc.
Decision Date2019-12-23
Product CodeHQB
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
MAXReach Laser Probe is a medical device manufactured by Vortex Surgical, Inc.. It received FDA 510(k) clearance on 2019-12-23 under approval number K191846. The device is classified under product code HQB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MAXReach Laser Probe?
MAXReach Laser Probe is a medical device that received FDA 510(k) clearance on 2019-12-23. It is manufactured by Vortex Surgical, Inc.. The 510(k) number is K191846.
When was MAXReach Laser Probe approved by the FDA?
MAXReach Laser Probe received FDA 510(k) clearance on 2019-12-23, under approval number K191846.
What company makes MAXReach Laser Probe?
MAXReach Laser Probe is manufactured by Vortex Surgical, Inc..
What is the FDA product code for MAXReach Laser Probe?
The FDA product code for MAXReach Laser Probe is HQB.
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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.