FDA 510(k)

COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0

K-Number: K040104 · 2004-02-18

Decision Date2004-02-18

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0 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 2004-02-18 under 510(k) number K040104. 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 ADHERE SURGICAL SYSTEM, MODEL M00415977C0?

COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0 is a medical device that received FDA 510(k) clearance on 2004-02-18. The listed applicant is Boston Scientific Corp. The 510(k) number is K040104.

When did COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0 receive FDA 510(k) clearance?

COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0 received FDA 510(k) clearance on 2004-02-18, under 510(k) number K040104.

Who is the listed applicant for COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0?

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 ADHERE SURGICAL SYSTEM, MODEL M00415977C0?

The FDA product code for COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0 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.