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FDA 510(k)

PENTAX FLEXIBLE DRIODENOFIBERSCOPE

K-Number: K812810 · 1981-11-17

ApplicantPentax Precision Instrument Corp.
Decision Date1981-11-17
Product CodeFAK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENTAX FLEXIBLE DRIODENOFIBERSCOPE 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 1981-11-17 under 510(k) number K812810. The device is classified under product code FAK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENTAX FLEXIBLE DRIODENOFIBERSCOPE?

PENTAX FLEXIBLE DRIODENOFIBERSCOPE is a medical device that received FDA 510(k) clearance on 1981-11-17. The listed applicant is Pentax Precision Instrument Corp.. The 510(k) number is K812810.

When did PENTAX FLEXIBLE DRIODENOFIBERSCOPE receive FDA 510(k) clearance?

PENTAX FLEXIBLE DRIODENOFIBERSCOPE received FDA 510(k) clearance on 1981-11-17, under 510(k) number K812810.

Who is the listed applicant for PENTAX FLEXIBLE DRIODENOFIBERSCOPE?

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 FLEXIBLE DRIODENOFIBERSCOPE?

The FDA product code for PENTAX FLEXIBLE DRIODENOFIBERSCOPE is FAK.

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Other records listing Pentax Precision Instrument Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K041397EG-3830UTK041396FG-36UX FIBER ULTRASOUND GASTROSCOPEK041395EG-3630URK031789EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023401EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023376EB-1830T3, VIDEO BRONCHOSCOPE

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Related Devices (Code: FAK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K760822MODEL TX-8 PANENDOSCOPEAmerican Cystocope Makers, Inc.

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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