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FDA 510(k)

BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25

K-Number: K081742 · 2008-09-17

ApplicantBaxano, Inc.
Decision Date2008-09-17
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 is the device name listed in this FDA 510(k) record. The listed applicant is Baxano, Inc.. It received FDA 510(k) clearance on 2008-09-17 under 510(k) number K081742. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25?

BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 is a medical device that received FDA 510(k) clearance on 2008-09-17. The listed applicant is Baxano, Inc.. The 510(k) number is K081742.

When did BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 receive FDA 510(k) clearance?

BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 received FDA 510(k) clearance on 2008-09-17, under 510(k) number K081742.

Who is the listed applicant for BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25?

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

What is the FDA product code for BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25?

The FDA product code for BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 is ETN.

Related Clinical Trials

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.

Other records listing Baxano, 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.

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Related Devices (Code: ETN)

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.

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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