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FDA 510(k)

IO-TOME DEVICE

K-Number: K113073 · 2012-07-27

ApplicantBaxano, Inc.
Decision Date2012-07-27
Product CodeHAE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

IO-TOME 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 2012-07-27 under 510(k) number K113073. The device is classified under product code HAE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IO-TOME DEVICE?

IO-TOME DEVICE is a medical device that received FDA 510(k) clearance on 2012-07-27. The listed applicant is Baxano, Inc.. The 510(k) number is K113073.

When did IO-TOME DEVICE receive FDA 510(k) clearance?

IO-TOME DEVICE received FDA 510(k) clearance on 2012-07-27, under 510(k) number K113073.

Who is the listed applicant for IO-TOME 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 IO-TOME DEVICE?

The FDA product code for IO-TOME DEVICE is HAE.

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Other records listing Baxano, 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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