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FDA 510(k)

BAXANO NEURO CHECK DEVICE

K-Number: K092729 · 2009-10-02

ApplicantBaxano, Inc.
Decision Date2009-10-02
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BAXANO NEURO CHECK DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Baxano, Inc.. It received FDA 510(k) clearance on 2009-10-02 under 510(k) number K092729. 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 NEURO CHECK DEVICE?

BAXANO NEURO CHECK DEVICE is a medical device that received FDA 510(k) clearance on 2009-10-02. The listed applicant is Baxano, Inc.. The 510(k) number is K092729.

When did BAXANO NEURO CHECK DEVICE receive FDA 510(k) clearance?

BAXANO NEURO CHECK DEVICE received FDA 510(k) clearance on 2009-10-02, under 510(k) number K092729.

Who is the listed applicant for BAXANO NEURO CHECK DEVICE?

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 NEURO CHECK DEVICE?

The FDA product code for BAXANO NEURO CHECK DEVICE is ETN.

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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.

K113073IO-TOME DEVICEK113533NEURO CHECK DEVICE WITH IO-FLEX WIREK110696NEURO CHECK DEVICE WITH IO-FLEX WIREK102594IO-FLEX CATHETERK100958MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIESK081742BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25

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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.

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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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