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FDA 510(k)

MICROFIX QUICKANCHOR PLUS

K-Number: K024115 · 2003-03-13

ApplicantMitek Worldwide
Decision Date2003-03-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MICROFIX QUICKANCHOR PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Mitek Worldwide. It received FDA 510(k) clearance on 2003-03-13 under 510(k) number K024115. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROFIX QUICKANCHOR PLUS?

MICROFIX QUICKANCHOR PLUS is a medical device that received FDA 510(k) clearance on 2003-03-13. The listed applicant is Mitek Worldwide. The 510(k) number is K024115.

When did MICROFIX QUICKANCHOR PLUS receive FDA 510(k) clearance?

MICROFIX QUICKANCHOR PLUS received FDA 510(k) clearance on 2003-03-13, under 510(k) number K024115.

Who is the listed applicant for MICROFIX QUICKANCHOR PLUS?

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

What is the FDA product code for MICROFIX QUICKANCHOR PLUS?

The FDA product code for MICROFIX QUICKANCHOR PLUS is HWC. This falls under the Cardiovascular category.

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Other records listing Mitek Worldwide as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K032717BIOCRYL RAPIDE INTERFERENCE SCREWK032167BIO-INTRAFIX TIBIAL SCREW AND SHEATHK032078MITEK MICRO QUICKANCHORK030995MINILOK QUICKANCHOR PLUSK031519CUFFLOK ANCHORK031406EXOJET TISSUE MANAGEMENT SYSTEM

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Related Devices (Code: HWC)

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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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