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FDA 510(k)

NEURO CHECK DEVICE WITH IO-FLEX WIRE

K-Number: K110696 · 2011-07-07

ApplicantBaxano, Inc.
Decision Date2011-07-07
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NEURO CHECK DEVICE WITH IO-FLEX WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Baxano, Inc.. It received FDA 510(k) clearance on 2011-07-07 under 510(k) number K110696. 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 NEURO CHECK DEVICE WITH IO-FLEX WIRE?

NEURO CHECK DEVICE WITH IO-FLEX WIRE is a medical device that received FDA 510(k) clearance on 2011-07-07. The listed applicant is Baxano, Inc.. The 510(k) number is K110696.

When did NEURO CHECK DEVICE WITH IO-FLEX WIRE receive FDA 510(k) clearance?

NEURO CHECK DEVICE WITH IO-FLEX WIRE received FDA 510(k) clearance on 2011-07-07, under 510(k) number K110696.

Who is the listed applicant for NEURO CHECK DEVICE WITH IO-FLEX WIRE?

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 NEURO CHECK DEVICE WITH IO-FLEX WIRE?

The FDA product code for NEURO CHECK DEVICE WITH IO-FLEX WIRE 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 WIREK102594IO-FLEX CATHETERK100958MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIESK092729BAXANO NEURO CHECK DEVICEK081742BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25

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Related Devices (Code: ETN)

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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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