FDA 510(k)

PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P

K-Number: K914008 · 1992-01-10

ApplicantPentax Precision Instrument Corp.

Decision Date1992-01-10

Product CodeFAJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Precision Instrument Corp.. It received FDA 510(k) clearance on 1992-01-10 under 510(k) number K914008. 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 PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P?

PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P is a medical device that received FDA 510(k) clearance on 1992-01-10. The listed applicant is Pentax Precision Instrument Corp.. The 510(k) number is K914008.

When did PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P receive FDA 510(k) clearance?

PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P received FDA 510(k) clearance on 1992-01-10, under 510(k) number K914008.

Who is the listed applicant for PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P?

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

What is the FDA product code for PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P?

The FDA product code for PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P 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.