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FDA 510(k)

ESSEX ENDOSCOPE, MODEL SXD-1000

K-Number: K023627 · 2002-11-12

ApplicantGuidant Corp.
Decision Date2002-11-12
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ESSEX ENDOSCOPE, MODEL SXD-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Corp.. It received FDA 510(k) clearance on 2002-11-12 under 510(k) number K023627. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESSEX ENDOSCOPE, MODEL SXD-1000?

ESSEX ENDOSCOPE, MODEL SXD-1000 is a medical device that received FDA 510(k) clearance on 2002-11-12. The listed applicant is Guidant Corp.. The 510(k) number is K023627.

When did ESSEX ENDOSCOPE, MODEL SXD-1000 receive FDA 510(k) clearance?

ESSEX ENDOSCOPE, MODEL SXD-1000 received FDA 510(k) clearance on 2002-11-12, under 510(k) number K023627.

Who is the listed applicant for ESSEX ENDOSCOPE, MODEL SXD-1000?

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

What is the FDA product code for ESSEX ENDOSCOPE, MODEL SXD-1000?

The FDA product code for ESSEX ENDOSCOPE, MODEL SXD-1000 is GCJ.

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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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