Colibri Endoscopy System

510(k) Number

K192305 ↗

FDA product code

EOB

FDA applicant

3nt Medical , Ltd.

Device class

Class II

Regulation

21 CFR Part 874.4760

Advisory committee

Ear, Nose, Throat

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code EOB (Nasopharyngoscope (Flexible Or Rigid)).

• Olympus WA4KS400 by Olympus Winter & Ibe GmbH
• ENDOSCOPE SHEATH by Xomed-Treace, Inc.
• SINUSCOPE AND ACCESSORIES by HENKE SASS WOLF OF AMERICA, INC.
• Olympus WA4KS445 by Olympus Winter & Ibe GmbH
• ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE by Entellus Medical
• SCOPESCRUBBER(TM) by Healthtek Microsurgical, Inc.
• LFRE INDIRECT LARYNGOSCOPE by Astralite Corp.
• VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID}) by JEDMED Instrument Company
• InstaClear LCS4K30TPOL by Gyrus Acmi, Inc.
• ENT Nasopharyngoscope and Accessories by Medimaging Integrated Solution, Inc (Miis)

• 3NT endoscopy system

  Class II

  FDA 510(k) K162916 Active Cleared 24 Feb 2017

• Sinusway Dilation System

  Class I

  FDA 510(k) K181838 Active Cleared 20 Dec 2018

• Peregrine Endoscopy System

  Class II

  FDA 510(k) K202727 Active Cleared 23 Jul 2021