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FDA 510(k)

AXIOM FASCIAL CLOSURE SYSTEM

K-Number: K103412 · 2010-12-30

ApplicantAxiom Technology Partners, LLC
Decision Date2010-12-30
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AXIOM FASCIAL CLOSURE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Axiom Technology Partners, LLC. It received FDA 510(k) clearance on 2010-12-30 under 510(k) number K103412. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXIOM FASCIAL CLOSURE SYSTEM?

AXIOM FASCIAL CLOSURE SYSTEM is a medical device that received FDA 510(k) clearance on 2010-12-30. The listed applicant is Axiom Technology Partners, LLC. The 510(k) number is K103412.

When did AXIOM FASCIAL CLOSURE SYSTEM receive FDA 510(k) clearance?

AXIOM FASCIAL CLOSURE SYSTEM received FDA 510(k) clearance on 2010-12-30, under 510(k) number K103412.

Who is the listed applicant for AXIOM FASCIAL CLOSURE SYSTEM?

The FDA 510(k) record lists Axiom Technology Partners, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AXIOM FASCIAL CLOSURE SYSTEM?

The FDA product code for AXIOM FASCIAL CLOSURE SYSTEM is OCW.

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Related Devices (Code: OCW)

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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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