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FDA 510(k)

SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT

K-Number: K113680 · 2011-12-29

ApplicantSoma Access Systems, LLC
Decision Date2011-12-29
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Soma Access Systems, LLC. It received FDA 510(k) clearance on 2011-12-29 under 510(k) number K113680. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT?

SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT is a medical device that received FDA 510(k) clearance on 2011-12-29. The listed applicant is Soma Access Systems, LLC. The 510(k) number is K113680.

When did SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT receive FDA 510(k) clearance?

SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT received FDA 510(k) clearance on 2011-12-29, under 510(k) number K113680.

Who is the listed applicant for SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT?

The FDA 510(k) record lists Soma Access Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT?

The FDA product code for SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT is IYO.

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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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