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FDA 510(k)

STATARIUS, MODEL 001 003

K-Number: K061292 · 2006-07-03

ApplicantKinetic Surgical, LLC
Decision Date2006-07-03
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STATARIUS, MODEL 001 003 is the device name listed in this FDA 510(k) record. The listed applicant is Kinetic Surgical, LLC. It received FDA 510(k) clearance on 2006-07-03 under 510(k) number K061292. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STATARIUS, MODEL 001 003?

STATARIUS, MODEL 001 003 is a medical device that received FDA 510(k) clearance on 2006-07-03. The listed applicant is Kinetic Surgical, LLC. The 510(k) number is K061292.

When did STATARIUS, MODEL 001 003 receive FDA 510(k) clearance?

STATARIUS, MODEL 001 003 received FDA 510(k) clearance on 2006-07-03, under 510(k) number K061292.

Who is the listed applicant for STATARIUS, MODEL 001 003?

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

What is the FDA product code for STATARIUS, MODEL 001 003?

The FDA product code for STATARIUS, MODEL 001 003 is GCJ.

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Other records listing Kinetic Surgical, LLC 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.

K072811MARIONETTE SA, MODEL 001 001 & 001 002

Related Devices (Code: GCJ)

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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