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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Blue Belt Technologies, Inc.. It received FDA 510(k) clearance on 2018-04-06 under 510(k) 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. The listed applicant is Blue Belt Technologies, Inc.. The 510(k) number is K180271.

When did NAVIO™ Surgical System (NAVIO system) receive FDA 510(k) clearance?

NAVIO™ Surgical System (NAVIO system) received FDA 510(k) clearance on 2018-04-06, under 510(k) number K180271.

Who is the listed applicant for NAVIO™ Surgical System (NAVIO system)?

The FDA 510(k) record lists Blue Belt Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NAVIO™ Surgical System (NAVIO system)?

The FDA product code for NAVIO™ Surgical System (NAVIO system) is OLO.

Other records listing Blue Belt Technologies, Inc. as applicant

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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.

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