Colibri Endoscopy System

Nasopharyngoscope (flexible Or Rigid)

3NT Medical Ltd.

The following data is part of a premarket notification filed by 3nt Medical Ltd. with the FDA for Colibri Endoscopy System.

Pre-market Notification Details

Device IDK192305
510k NumberK192305
Device Name:Colibri Endoscopy System
ClassificationNasopharyngoscope (flexible Or Rigid)
Applicant 3NT Medical Ltd. 22 HaMelacha St., POB 11384 Rosh Ha’ayin,  IL 4809169
ContactEhud Bendory
CorrespondentOrly Maor
Orly Maor 25A Sirkin Street Kfar Saba,  IL 4442156
Product CodeEOB  
CFR Regulation Number874.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyEar Nose & Throat
510k Review PanelEar Nose & Throat
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-23
Decision Date2020-02-27

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