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

FDA 510(k)

EW10-EC02 Endoscopy Support Program

K-Number: K230751 · 2023-12-15

ApplicantFujifilm Corporation
Decision Date2023-12-15
Product CodeQNP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EW10-EC02 Endoscopy Support Program is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2023-12-15 under approval number K230751. The device is classified under product code QNP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EW10-EC02 Endoscopy Support Program?

EW10-EC02 Endoscopy Support Program is a medical device that received FDA 510(k) clearance on 2023-12-15. It is manufactured by Fujifilm Corporation. The 510(k) number is K230751.

When was EW10-EC02 Endoscopy Support Program approved by the FDA?

EW10-EC02 Endoscopy Support Program received FDA 510(k) clearance on 2023-12-15, under approval number K230751.

What company makes EW10-EC02 Endoscopy Support Program?

EW10-EC02 Endoscopy Support Program is manufactured by Fujifilm Corporation.

What is the FDA product code for EW10-EC02 Endoscopy Support Program?

The FDA product code for EW10-EC02 Endoscopy Support Program is QNP.

Related Clinical Trials

NCT07370051 Effect of Topical Oxygen and LED Light Therapy on Nipple Crack NOT_YET_RECRUITING NCT07039084 Using a Speech-Generating Device to Support Communication in Rare Genetic Conditions RECRUITING NCT07372872 Feasibility Testing of the "MyGlucoCare" Smartphone App for Women With Gestational Diabetes RECRUITING NCT07440004 Testing a Digital Mindfulness Program to Support People Experiencing Suicidal Thoughts RECRUITING NCT07598604 Early Mobilization and Equinus Correction in Spastic Cerebral Palsy NOT_YET_RECRUITING NCT07093645 Serious Game-Based School Intervention to Enhance Socio-Emotional Competence and Well-Being in European Adolescents ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 39950674 Contemporary Landscape of Medical Technology in Gastroenterology Between 2013 and 2023. The American journal of gastroenterology (2025)

Other Devices by Fujifilm Corporation

K182051FUJIFILM Duodenoscope Model K181773Synapse 3D Optional Tools K180341FUJIFILM 600 Series Endoscope EG-600WR v2 K181763FUJIFILM Ultrasonic Endoscope K180711FUJIFILM Endoscopic CO2 Regulator GW-100 K180405FUJIFILM Endoscope Models EC-600HL and EC-600LS

View all 62 devices →

Related Devices (Code: QNP)

K211326EndoScreenerChengdu Wision Medical Device Co., Ltd. K211951GI GeniusCosmo Artificial Intelligence - Ai, Ltd. DEN200055GI GeniusCosmo Artificial Intelligence - Ai, Ltd. K213686SKOUT SoftwareIterative Scopes, Inc. K223473ME-APDS™; MAGENTIQ-COLO™Magentiq Eye, Ltd. K231143GI Genius System 100 and GI Genius System 200Cosmo Artificial Intelligence - Ai, Ltd.

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.

↑