HI-Q Hand Instruments - Urology

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

510(k) Number

K944201 ↗

FDA Product Code

GCJ

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 are the Olympus HI-Q Hand Instruments - Urology designed for?

  The Olympus HI-Q Hand Instruments - Urology are specifically designed for surgical procedures within the urological system. They are intended for precise tasks such as tissue manipulation, dissection, and coagulation during both minimally invasive and open surgeries. Their ergonomic design and specialized features help clinicians achieve better control and minimize tissue trauma, which can improve procedural outcomes.

• Are these instruments meant for single-use or reusable?

  These instruments are supplied sterile for single-use only. Olympus has classified them this way to ensure patient safety and maintain sterility, reducing the risk of cross-contamination between procedures. Single-use instruments also eliminate the need for reprocessing, which can be time-consuming and may introduce additional risks if not done correctly.

• How should these instruments be stored to maintain sterility?

  To preserve sterility and functionality, these instruments must be stored according to Olympus’s guidelines. They should remain in their original, unopened packaging until immediately before use. The packaging is designed to protect against contamination, so any breach—such as removing the instrument prematurely—could compromise sterility. Store in a clean, dry environment away from direct sunlight or extreme temperatures.

• What regulatory clearance does the HI-Q Urology Hand Instruments hold?

  The Olympus HI-Q Hand Instruments - Urology carry FDA 510(k) clearance (K944201), classified under product code GCJ. This clearance was granted in 1994 after a review by the Gastroenterology and Urology advisory committees, determining the device to be *substantially equivalent* to a legally marketed predicate. The clearance confirms compliance with U.S. regulatory requirements for surgical hand instruments in urology.

• Can these instruments be used in both open and minimally invasive urological surgeries?

  Yes, the HI-Q Hand Instruments - Urology are intended for use in both open and minimally invasive urological surgeries. Their ergonomic and specialized design supports precise manipulation and reduced tissue trauma, making them versatile for a range of procedures. However, clinicians should always follow manufacturer instructions and best practices for the specific surgical approach being performed.