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FDA 510(k)

SOVEREIGN MINI

K-Number: K123102 · 2013-01-03

ApplicantAesculap, Inc.
Decision Date2013-01-03
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SOVEREIGN MINI is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2013-01-03 under 510(k) number K123102. 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 SOVEREIGN MINI?

SOVEREIGN MINI is a medical device that received FDA 510(k) clearance on 2013-01-03. The listed applicant is Aesculap, Inc.. The 510(k) number is K123102.

When did SOVEREIGN MINI receive FDA 510(k) clearance?

SOVEREIGN MINI received FDA 510(k) clearance on 2013-01-03, under 510(k) number K123102.

Who is the listed applicant for SOVEREIGN MINI?

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

What is the FDA product code for SOVEREIGN MINI?

The FDA product code for SOVEREIGN MINI is GCJ.

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Related Devices (Code: GCJ)

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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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