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FDA 510(k)

3 CCD ENDOCAM 5550

K-Number: K080977 · 2008-05-14

ApplicantRichard Wolf Medical Instruments Corp.
Decision Date2008-05-14
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

3 CCD ENDOCAM 5550 is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 2008-05-14 under 510(k) number K080977. 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 3 CCD ENDOCAM 5550?

3 CCD ENDOCAM 5550 is a medical device that received FDA 510(k) clearance on 2008-05-14. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K080977.

When did 3 CCD ENDOCAM 5550 receive FDA 510(k) clearance?

3 CCD ENDOCAM 5550 received FDA 510(k) clearance on 2008-05-14, under 510(k) number K080977.

Who is the listed applicant for 3 CCD ENDOCAM 5550?

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

What is the FDA product code for 3 CCD ENDOCAM 5550?

The FDA product code for 3 CCD ENDOCAM 5550 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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