Peregrine Endoscopy System

510(k) Number

K202727 ↗

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)).

• PENTAX Medical EPK-3000 Video Imaging System by Pentax Medical Company
• 091330-01 by Karl Storz SE & CO. KG
• Sharpsite AC Rigid Endsocope by Medtronic Xomed Inc
• KARL STORZ RIGID TELESCOPES FOR ENT ENDOSCOPIC PROCEDURES by Karl Storz Endoscopy-America, Inc.
• RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP by Olympus Medical Systems Corporation
• SLIM-LINE 8705CKA by Karl Storz SE & CO. KG
• CMOS Video Nasopharyngoscope System by Schoelly Fiberoptic GmbH
• POC ENT ENDOSCOPE - SINUSCOPE by PRECISION OPTICS CORP.
• FORCEPS, PUNCHES, SCISSORS by Karl Storz Endoscopy-America, Inc.
• ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE by ACCLARENT, INC.

• 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

• Colibri Endoscopy System

  Class II

  FDA 510(k) K192305 Active Cleared 27 Feb 2020