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FDA 510(k)

ESTECH COBRA(R) GENESIS BIPOLAR CLAMP

K-Number: K133017 · 2013-10-07

ApplicantEstech, Inc.
Decision Date2013-10-07
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ESTECH COBRA(R) GENESIS BIPOLAR CLAMP is the device name listed in this FDA 510(k) record. The listed applicant is Estech, Inc.. It received FDA 510(k) clearance on 2013-10-07 under 510(k) number K133017. 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 ESTECH COBRA(R) GENESIS BIPOLAR CLAMP?

ESTECH COBRA(R) GENESIS BIPOLAR CLAMP is a medical device that received FDA 510(k) clearance on 2013-10-07. The listed applicant is Estech, Inc.. The 510(k) number is K133017.

When did ESTECH COBRA(R) GENESIS BIPOLAR CLAMP receive FDA 510(k) clearance?

ESTECH COBRA(R) GENESIS BIPOLAR CLAMP received FDA 510(k) clearance on 2013-10-07, under 510(k) number K133017.

Who is the listed applicant for ESTECH COBRA(R) GENESIS BIPOLAR CLAMP?

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

What is the FDA product code for ESTECH COBRA(R) GENESIS BIPOLAR CLAMP?

The FDA product code for ESTECH COBRA(R) GENESIS BIPOLAR CLAMP is GEI.

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Other records listing Estech, Inc. as applicant

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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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