Ltf-240 Pleuravideoscope, Its Accessories and Ancillary Equipments

• 2 recalls, same reason

  • Terminated Z-1762-2020 FDA Class II ·initiated 23 Mar 2020
  • Terminated Z-1763-2020 FDA Class II ·initiated 23 Mar 2020

  There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations Manuals are being provided.

510(k) Number

K013617 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Hx-5/6-1 Endoscopic Clipping Device, Endoscopic Clips

  Class II

  FDA 510(k) K990687 Active Cleared 26 Mar 1999

• Olympus Ultrasonic Gastrovideoscope Gf Type UC140P-DO5 & Olympus Ultrasonic Gastrofiberscope Gf Type UC30P

  Class II

  FDA 510(k) K021886 Active Cleared 19 Jun 2002

• Olympus Ultrasonic Surgical System

  Unclassified

  FDA 510(k) K031305 Active Cleared 23 Sep 2003

• Olympus Neuro Endoscope

  Class II

  FDA 510(k) K971340 Active Cleared 29 Jul 1998

• Evis Exera Bronchofibervideoscope Olympus Bf Type XP160F, Its Accessories and Ancillary Equipment Open recall

  Class II

  FDA 510(k) K033225 Active Cleared 16 Oct 2003

• Heat Scissors Generator Set and Heat Scissors Handpiece

  Class II

  FDA 510(k) K024138 Active Cleared 12 Mar 2003

See all devices from Olympus Optical Co., Ltd. →