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FDA 510(k)

3NT endoscopy system

K-Number: K162916 · 2017-02-24

Applicant3nt Medical , Ltd.
Decision Date2017-02-24
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

3NT endoscopy system is a medical device manufactured by 3nt Medical , Ltd.. It received FDA 510(k) clearance on 2017-02-24 under approval number K162916. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3NT endoscopy system?

3NT endoscopy system is a medical device that received FDA 510(k) clearance on 2017-02-24. It is manufactured by 3nt Medical , Ltd.. The 510(k) number is K162916.

When was 3NT endoscopy system approved by the FDA?

3NT endoscopy system received FDA 510(k) clearance on 2017-02-24, under approval number K162916.

What company makes 3NT endoscopy system?

3NT endoscopy system is manufactured by 3nt Medical , Ltd..

What is the FDA product code for 3NT endoscopy system?

The FDA product code for 3NT endoscopy system is EOB.

Related Clinical Trials

NCT07587437 Preoperative Use of a Magnetically Controlled Capsule Endoscopy in Patients Undergoing Bariatric Surgery ENROLLING_BY_INVITATION NCT05822895 Review of the Impact of a Computer-aided Real-time Polyp Detection System on Adult Colonoscopy RECRUITING NCT06691919 Surgical vs Endoscopic Resection of Walled Off Pancreatic Necrosis Using the Powered Endoscopic Debridement System WITHDRAWN NCT07489157 Real-Time End-Tidal Carbon Dioxide Monitoring for Early Warning of Hypoxemia in Painless Gastrointestinal Endoscopy NOT_YET_RECRUITING

Other Devices by 3nt Medical , Ltd.

K181838Sinusway Dilation System K192305Colibri Endoscopy System K202727Peregrine Endoscopy System

Related Devices (Code: EOB)

K153701ULYSS Multi View SinuscopeSopro-Comeg GmbH K153009ULTRA TelescopesOlympus Winter & Ibe GmbH K152531InstaClear Lens CleanerGyrus Acmi, Inc. K170453Medrobotics Flex Robotic SystemMedrobotics Corporation K161298ShenDa SinuscopeShenyang Shenda Endoscope Co., Ltd. K170285AED SinuscopeNational Advanced Endoscopy Devices, 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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