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FDA 510(k)

PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA

K-Number: K904573 · 1991-06-12

ApplicantPentax Precision Instrument Corp.
Decision Date1991-06-12
Product CodeODG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA 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 1991-06-12 under 510(k) number K904573. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA?

PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA is a medical device that received FDA 510(k) clearance on 1991-06-12. The listed applicant is Pentax Precision Instrument Corp.. The 510(k) number is K904573.

When did PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA receive FDA 510(k) clearance?

PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA received FDA 510(k) clearance on 1991-06-12, under 510(k) number K904573.

Who is the listed applicant for PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA?

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 ULTRASOUND ENDOSCOPE, MODEL FG-32UA?

The FDA product code for PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA is ODG.

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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.

K041396FG-36UX FIBER ULTRASOUND GASTROSCOPEK041397EG-3830UTK041395EG-3630URK031789EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023401EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023376EB-1830T3, VIDEO BRONCHOSCOPE

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Related Devices (Code: ODG)

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.

K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems CorporationK260428RIVOS™ EUS Access Device (M00553900)Boston Scientific CorporationK251859EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems CorporationK251542InstaFANOnepass Medical , Ltd.K231813Ultrasonic GastrovideoscopeSonoscape Medical Corp.K232518EndoSound Vision System; EVSEndosound, 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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