NAVIO Surgical System (NAVIO system)
K-Number: K180271 · 2018-04-06
ApplicantBlue Belt Technologies, Inc.
Decision Date2018-04-06
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
NAVIO Surgical System (NAVIO system) is a medical device manufactured by Blue Belt Technologies, Inc.. It received FDA 510(k) clearance on 2018-04-06 under approval number K180271. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NAVIO Surgical System (NAVIO system)?
NAVIO Surgical System (NAVIO system) is a medical device that received FDA 510(k) clearance on 2018-04-06. It is manufactured by Blue Belt Technologies, Inc.. The 510(k) number is K180271.
When was NAVIO Surgical System (NAVIO system) approved by the FDA?
NAVIO Surgical System (NAVIO system) received FDA 510(k) clearance on 2018-04-06, under approval number K180271.
What company makes NAVIO Surgical System (NAVIO system)?
NAVIO Surgical System (NAVIO system) is manufactured by Blue Belt Technologies, Inc..
What is the FDA product code for NAVIO Surgical System (NAVIO system)?
The FDA product code for NAVIO Surgical System (NAVIO system) is OLO.
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Official Source
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