FDA 510(k)

COBRA COOLED SURGICAL PROBE, MODEL 1596X

K-Number: K021046 · 2002-04-16

Decision Date2002-04-16

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

COBRA COOLED SURGICAL PROBE, MODEL 1596X 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 2002-04-16 under 510(k) number K021046. 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 1596X?

COBRA COOLED SURGICAL PROBE, MODEL 1596X is a medical device that received FDA 510(k) clearance on 2002-04-16. The listed applicant is Boston Scientific Corp. The 510(k) number is K021046.

When did COBRA COOLED SURGICAL PROBE, MODEL 1596X receive FDA 510(k) clearance?

COBRA COOLED SURGICAL PROBE, MODEL 1596X received FDA 510(k) clearance on 2002-04-16, under 510(k) number K021046.

Who is the listed applicant for COBRA COOLED SURGICAL PROBE, MODEL 1596X?

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 1596X?

The FDA product code for COBRA COOLED SURGICAL PROBE, MODEL 1596X 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.