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FDA 510(k)

EG-3870UTK

K-Number: K090197 · 2009-05-19

ApplicantPentax Medical Company
Decision Date2009-05-19
Product CodeODG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EG-3870UTK is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Medical Company. It received FDA 510(k) clearance on 2009-05-19 under 510(k) number K090197. 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-3870UTK?

EG-3870UTK is a medical device that received FDA 510(k) clearance on 2009-05-19. The listed applicant is Pentax Medical Company. The 510(k) number is K090197.

When did EG-3870UTK receive FDA 510(k) clearance?

EG-3870UTK received FDA 510(k) clearance on 2009-05-19, under 510(k) number K090197.

Who is the listed applicant for EG-3870UTK?

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

What is the FDA product code for EG-3870UTK?

The FDA product code for EG-3870UTK is ODG.

Other records listing Pentax Medical Company 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.

K093037PENTEX EC-3890LIK092710PENTAX ED-3490TK, VIDEO DUODENOSCOPEK090196EG-3670URKK081518ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UKK061068EG-3670URKK042741EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE

View all 8 devices →

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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