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FDA 510(k)

SPiN Thoracic Navigation System

K-Number: K170023 · 2017-05-15

ApplicantVeran Medical Technologies, Inc.
Decision Date2017-05-15
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SPiN Thoracic Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Veran Medical Technologies, Inc.. It received FDA 510(k) clearance on 2017-05-15 under 510(k) number K170023. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPiN Thoracic Navigation System?

SPiN Thoracic Navigation System is a medical device that received FDA 510(k) clearance on 2017-05-15. The listed applicant is Veran Medical Technologies, Inc.. The 510(k) number is K170023.

When did SPiN Thoracic Navigation System receive FDA 510(k) clearance?

SPiN Thoracic Navigation System received FDA 510(k) clearance on 2017-05-15, under 510(k) number K170023.

Who is the listed applicant for SPiN Thoracic Navigation System?

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

What is the FDA product code for SPiN Thoracic Navigation System?

The FDA product code for SPiN Thoracic Navigation System is JAK.

Other records listing Veran Medical Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202346SPiN Vision Video Bronchoscope System

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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