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FDA 510(k)

XTOOL

K-Number: K122861 · 2012-12-07

ApplicantOuroboros Medical
Decision Date2012-12-07
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

XTOOL is the device name listed in this FDA 510(k) record. The listed applicant is Ouroboros Medical. It received FDA 510(k) clearance on 2012-12-07 under 510(k) number K122861. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XTOOL?

XTOOL is a medical device that received FDA 510(k) clearance on 2012-12-07. The listed applicant is Ouroboros Medical. The 510(k) number is K122861.

When did XTOOL receive FDA 510(k) clearance?

XTOOL received FDA 510(k) clearance on 2012-12-07, under 510(k) number K122861.

Who is the listed applicant for XTOOL?

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

What is the FDA product code for XTOOL?

The FDA product code for XTOOL is HRX.

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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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