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FDA 510(k)

EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE

K-Number: K023401 · 2003-02-11

ApplicantPentax Precision Instrument Corp.
Decision Date2003-02-11
Product CodeODG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE 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 2003-02-11 under 510(k) number K023401. 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 EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE?

EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE is a medical device that received FDA 510(k) clearance on 2003-02-11. The listed applicant is Pentax Precision Instrument Corp.. The 510(k) number is K023401.

When did EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE receive FDA 510(k) clearance?

EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE received FDA 510(k) clearance on 2003-02-11, under 510(k) number K023401.

Who is the listed applicant for EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE?

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 EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE?

The FDA product code for EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE 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 GASTROSCOPEK041395EG-3630URK041397EG-3830UTK031789EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023376EB-1830T3, VIDEO BRONCHOSCOPEK021276FG-36UX FIBER ULTRASOUND GASTROSCOPE

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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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