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FDA 510(k)

SOVEREIGN BIPOLAR INSTRUMENTS

K-Number: K001330 · 2000-05-30

ApplicantAesculap, Inc.
Decision Date2000-05-30
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOVEREIGN BIPOLAR INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2000-05-30 under 510(k) number K001330. 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 SOVEREIGN BIPOLAR INSTRUMENTS?

SOVEREIGN BIPOLAR INSTRUMENTS is a medical device that received FDA 510(k) clearance on 2000-05-30. The listed applicant is Aesculap, Inc.. The 510(k) number is K001330.

When did SOVEREIGN BIPOLAR INSTRUMENTS receive FDA 510(k) clearance?

SOVEREIGN BIPOLAR INSTRUMENTS received FDA 510(k) clearance on 2000-05-30, under 510(k) number K001330.

Who is the listed applicant for SOVEREIGN BIPOLAR INSTRUMENTS?

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 BIPOLAR INSTRUMENTS?

The FDA product code for SOVEREIGN BIPOLAR INSTRUMENTS is GEI.

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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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