FDA 510(k)

CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C

K-Number: K093725 · 2010-08-30

Decision Date2010-08-30

Product CodeFAJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C is the device name listed in this FDA 510(k) record. The listed applicant is Canada Endoscope Corporation. It received FDA 510(k) clearance on 2010-08-30 under 510(k) number K093725. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C?

CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C is a medical device that received FDA 510(k) clearance on 2010-08-30. The listed applicant is Canada Endoscope Corporation. The 510(k) number is K093725.

When did CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C receive FDA 510(k) clearance?

CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C received FDA 510(k) clearance on 2010-08-30, under 510(k) number K093725.

Who is the listed applicant for CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C?

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

What is the FDA product code for CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C?

The FDA product code for CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C is FAJ.

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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.