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FDA 510(k)

BAXANO ULTRA LOW PROFILE RONGEUR

K-Number: K080494 · 2008-03-04

ApplicantBaxano, Inc.
Decision Date2008-03-04
Product CodeHAE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BAXANO ULTRA LOW PROFILE RONGEUR is the device name listed in this FDA 510(k) record. The listed applicant is Baxano, Inc.. It received FDA 510(k) clearance on 2008-03-04 under 510(k) number K080494. 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 BAXANO ULTRA LOW PROFILE RONGEUR?

BAXANO ULTRA LOW PROFILE RONGEUR is a medical device that received FDA 510(k) clearance on 2008-03-04. The listed applicant is Baxano, Inc.. The 510(k) number is K080494.

When did BAXANO ULTRA LOW PROFILE RONGEUR receive FDA 510(k) clearance?

BAXANO ULTRA LOW PROFILE RONGEUR received FDA 510(k) clearance on 2008-03-04, under 510(k) number K080494.

Who is the listed applicant for BAXANO ULTRA LOW PROFILE RONGEUR?

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 ULTRA LOW PROFILE RONGEUR?

The FDA product code for BAXANO ULTRA LOW PROFILE RONGEUR is HAE.

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Other records listing Baxano, Inc. as applicant

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K113073IO-TOME DEVICEK113533NEURO CHECK DEVICE WITH IO-FLEX WIREK110696NEURO CHECK DEVICE WITH IO-FLEX WIREK102594IO-FLEX CATHETERK100958MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIESK092729BAXANO NEURO CHECK DEVICE

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Related Devices (Code: HAE)

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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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