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FDA 510(k)

EXOJET TISSUE MANAGEMENT SYSTEM

K-Number: K031406 · 2003-05-30

ApplicantMitek Worldwide
Decision Date2003-05-30
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXOJET TISSUE MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mitek Worldwide. It received FDA 510(k) clearance on 2003-05-30 under 510(k) number K031406. 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 EXOJET TISSUE MANAGEMENT SYSTEM?

EXOJET TISSUE MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2003-05-30. The listed applicant is Mitek Worldwide. The 510(k) number is K031406.

When did EXOJET TISSUE MANAGEMENT SYSTEM receive FDA 510(k) clearance?

EXOJET TISSUE MANAGEMENT SYSTEM received FDA 510(k) clearance on 2003-05-30, under 510(k) number K031406.

Who is the listed applicant for EXOJET TISSUE MANAGEMENT SYSTEM?

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 EXOJET TISSUE MANAGEMENT SYSTEM?

The FDA product code for EXOJET TISSUE MANAGEMENT SYSTEM is HRX.

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Other records listing Mitek Worldwide as applicant

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Related Devices (Code: HRX)

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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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