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FDA 510(k)

ESTECH COBRA BIPOLSR II

K-Number: K100224 · 2010-04-07

ApplicantEndoscopic Technologies, Inc. D/B/A Estech
Decision Date2010-04-07
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ESTECH COBRA BIPOLSR II is the device name listed in this FDA 510(k) record. The listed applicant is Endoscopic Technologies, Inc. D/B/A Estech. It received FDA 510(k) clearance on 2010-04-07 under 510(k) number K100224. 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 BIPOLSR II?

ESTECH COBRA BIPOLSR II is a medical device that received FDA 510(k) clearance on 2010-04-07. The listed applicant is Endoscopic Technologies, Inc. D/B/A Estech. The 510(k) number is K100224.

When did ESTECH COBRA BIPOLSR II receive FDA 510(k) clearance?

ESTECH COBRA BIPOLSR II received FDA 510(k) clearance on 2010-04-07, under 510(k) number K100224.

Who is the listed applicant for ESTECH COBRA BIPOLSR II?

The FDA 510(k) record lists Endoscopic Technologies, Inc. D/B/A Estech as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESTECH COBRA BIPOLSR II?

The FDA product code for ESTECH COBRA BIPOLSR II is GEI.

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Other records listing Endoscopic Technologies, Inc. D/B/A Estech 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.

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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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