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FDA 510(k)

COBRA SURGICAL SYSTEM

K-Number: K051749 · 2005-09-13

ApplicantEstech, Inc.
Decision Date2005-09-13
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COBRA SURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Estech, Inc.. It received FDA 510(k) clearance on 2005-09-13 under 510(k) number K051749. 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 COBRA SURGICAL SYSTEM?

COBRA SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 2005-09-13. The listed applicant is Estech, Inc.. The 510(k) number is K051749.

When did COBRA SURGICAL SYSTEM receive FDA 510(k) clearance?

COBRA SURGICAL SYSTEM received FDA 510(k) clearance on 2005-09-13, under 510(k) number K051749.

Who is the listed applicant for COBRA SURGICAL SYSTEM?

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 COBRA SURGICAL SYSTEM?

The FDA product code for COBRA SURGICAL SYSTEM is GEI.

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Other records listing Estech, 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.

K133017ESTECH COBRA(R) GENESIS BIPOLAR CLAMPK053021ESTECH CLEARVIEW MV ATRIAL DEPRESSORK052081REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULAK041599COBRA ADHERE SURGICAL SYSTEMK032632REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCHK990573ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA

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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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