Olympus Oes OTV-S5C Video System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K971416 ↗

FDA Product Code

FET

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• 3D Surgical Endoscopy System for General Surgery

  Class II

  FDA 510(k) K943307 Active Cleared 20 Dec 1995

• Olympus Fg-45/46-1 Grasping Forceps

  Class II

  FDA 510(k) K955049 Active Cleared 15 Dec 1995

• Olympus Unsaturated Iron Binding Capacity Reagent

  Class I

  FDA 510(k) K955139 Active Cleared 12 Feb 1996

• Olympus Fb Series Biopsy Forceps

  Class II

  FDA 510(k) K962555 Active Cleared 30 Jul 1996

• Olympus Fd-5 Hot Biopsy Forceps

  Class II

  FDA 510(k) K951445 Active Cleared 3 May 1995

• Olympus Biopsy Forceps Model Fb-44

  Class II

  FDA 510(k) K950786 Active Cleared 6 Mar 1995

See all devices from Olympus America, Inc. →

• What is the primary purpose of the Olympus OES OTV-S5C Video System?

  The Olympus OES OTV-S5C is an endoscopic video imaging system designed to facilitate the visualization of internal body cavities during diagnostic and therapeutic procedures.

• Which medical specialties is this video system designed for?

  This system is specifically intended for use within the medical fields of gastroenterology and urology.

• How is the Olympus OES OTV-S5C Video System supplied?

  The system is supplied as a camera control unit to support endoscopic imaging requirements.

• What is the regulatory status of this device?

  The device is subject to FDA 510(k) authorization, which was granted under K971416.