FDA 510(k)

COBRA COOLED SURGICAL PROBE, MODEL M004159670

K-Number: K032207 · 2003-08-20

Decision Date2003-08-20

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

COBRA COOLED SURGICAL PROBE, MODEL M004159670 is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2003-08-20 under 510(k) number K032207. 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 COOLED SURGICAL PROBE, MODEL M004159670?

COBRA COOLED SURGICAL PROBE, MODEL M004159670 is a medical device that received FDA 510(k) clearance on 2003-08-20. The listed applicant is Boston Scientific Corp. The 510(k) number is K032207.

When did COBRA COOLED SURGICAL PROBE, MODEL M004159670 receive FDA 510(k) clearance?

COBRA COOLED SURGICAL PROBE, MODEL M004159670 received FDA 510(k) clearance on 2003-08-20, under 510(k) number K032207.

Who is the listed applicant for COBRA COOLED SURGICAL PROBE, MODEL M004159670?

The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COBRA COOLED SURGICAL PROBE, MODEL M004159670?

The FDA product code for COBRA COOLED SURGICAL PROBE, MODEL M004159670 is GEI.

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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.