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)

Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear

K-Number: K163492 · 2017-01-06

ApplicantUnited States Endoscopy Group, Inc.
Decision Date2017-01-06
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear is a medical device manufactured by United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2017-01-06 under approval number K163492. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear?

Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear is a medical device that received FDA 510(k) clearance on 2017-01-06. It is manufactured by United States Endoscopy Group, Inc.. The 510(k) number is K163492.

When was Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear approved by the FDA?

Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear received FDA 510(k) clearance on 2017-01-06, under approval number K163492.

What company makes Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear?

Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear is manufactured by United States Endoscopy Group, Inc..

What is the FDA product code for Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear?

The FDA product code for Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear is FDF.

Related Clinical Trials

NCT04996173 Cryospray Therapy Versus Standard of Care for Benign Airway Stenosis (CryoStasis) ACTIVE_NOT_RECRUITING

Other Devices by United States Endoscopy Group, Inc.

K172805gi-4000 Electrosurgical Generator K163495AdvanCE capsule endoscope delivery device K182909Roth Net Retriever Product Line K182258AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm K173650AquaShield System CO2- Fujifilm K192059Bio Guard Air/Water & Suction Valves

View all 10 devices →

Related Devices (Code: FDF)

K162428DiLumen Endolumenal Interventional PlatformLumendi, LLC K162622Fujifilm Endoscope Models EC-600HL and EC-600LSFujifilm Medical Systems U.S.A, Inc. K160015Pure VuMotus GI Medical Technologies , Ltd. K161355invendoscopy E200 SystemInvendo Medical GmbH K161791Aer-O-Scope Colonoscope SystemGi View , Ltd. K160356Third Eye Panoramic Auxiliary Endoscopy System - ResposableAvantis Medical Systems, 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.

↑