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FDA 510(k)

FINESSE SYSTEM

K-Number: K072261 · 2007-12-26

ApplicantPrimaeva Medical, Inc.
Decision Date2007-12-26
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FINESSE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Primaeva Medical, Inc.. It received FDA 510(k) clearance on 2007-12-26 under 510(k) number K072261. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FINESSE SYSTEM?

FINESSE SYSTEM is a medical device that received FDA 510(k) clearance on 2007-12-26. The listed applicant is Primaeva Medical, Inc.. The 510(k) number is K072261.

When did FINESSE SYSTEM receive FDA 510(k) clearance?

FINESSE SYSTEM received FDA 510(k) clearance on 2007-12-26, under 510(k) number K072261.

Who is the listed applicant for FINESSE SYSTEM?

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

What is the FDA product code for FINESSE SYSTEM?

The FDA product code for FINESSE SYSTEM is GEI.

Related Clinical Trials

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.

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Other records listing Primaeva Medical, Inc. 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.

K082391PRIMAEVA MEDICAL RENESIS SYSTEMK080145PRIMAEVA MEDICAL SYSTEM

Related Devices (Code: GEI)

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.

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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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