Olympus Laparoscopic Ultrasound System

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

510(k) Number

K944017 ↗

FDA Product Code

ITX

Device Class

Class II

Regulation

21 CFR Part 892.1570

Advisory Committee

Radiology

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 Olympus Laparoscopic Ultrasound System used for?

  The Olympus Laparoscopic Ultrasound System is a Class II ultrasound system designed for use in laparoscopic procedures, providing imaging capabilities during minimally invasive surgical procedures.

• Is the Olympus Laparoscopic Ultrasound System reusable or single-use?

  The Olympus Laparoscopic Ultrasound System is supplied as a reusable device, meaning it can be used multiple times following proper sterilization and maintenance according to manufacturer instructions.

• What regulatory approvals does the Olympus Laparoscopic Ultrasound System have?

  The Olympus Laparoscopic Ultrasound System received FDA 510(k) clearance with K-number K944017 in 1995, classified as substantially equivalent to predicate devices in the ITX product code category.

• How should the Olympus Laparoscopic Ultrasound System be stored?

  The Olympus Laparoscopic Ultrasound System should be stored according to manufacturer instructions, though specific storage requirements are not detailed in the provided information.