Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FUJIFILM Ultrasonic Endoscope

K-Number: K183433 · 2019-09-05

ApplicantFujifilm Corporation
Decision Date2019-09-05
Product CodeODG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Ultrasonic Endoscope is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2019-09-05 under 510(k) number K183433. 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 FUJIFILM Ultrasonic Endoscope?

FUJIFILM Ultrasonic Endoscope is a medical device that received FDA 510(k) clearance on 2019-09-05. The listed applicant is Fujifilm Corporation. The 510(k) number is K183433.

When did FUJIFILM Ultrasonic Endoscope receive FDA 510(k) clearance?

FUJIFILM Ultrasonic Endoscope received FDA 510(k) clearance on 2019-09-05, under 510(k) number K183433.

Who is the listed applicant for FUJIFILM Ultrasonic Endoscope?

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

What is the FDA product code for FUJIFILM Ultrasonic Endoscope?

The FDA product code for FUJIFILM Ultrasonic Endoscope is ODG.

Other records listing Fujifilm Corporation 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.

K261170BA-004CCK260567EW10-EC02 Endoscopy Support ProgramK261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TK254075Synapse Lung Nodule AIK254189Synapse 3D Base Tools (V7.2)

View all 67 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.

↑