Laparoscope

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

510(k) Number

K950076 ↗

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 is the Laparoscope used for in surgical procedures?

  The Laparoscope is a rigid endoscope designed for minimally invasive diagnostic and surgical procedures within the abdominal or pelvic cavities. It transmits light and visual images to an external viewing device, allowing surgeons to assess internal tissues and structures in real time. Common applications include cholecystectomy, hernia repair, and gynecological surgeries, where it helps achieve precision while minimizing patient trauma compared to traditional open surgery.

• Is the Laparoscope a single-use or reusable device?

  The Laparoscope is a reusable device intended for use in sterile operating room environments. To prevent cross-contamination between procedures, it must be thoroughly cleaned, disinfected, and sterilized following manufacturer guidelines. Proper maintenance is essential to preserve its optical clarity and structural integrity for repeated use.

• What sizes and configurations are available for the Laparoscope?

  The Laparoscope comes in various sizes and configurations, including standard and angled models. These variations accommodate different anatomical access points and surgical needs, ensuring flexibility for a range of procedures. The specific models should be reviewed in the manufacturer’s documentation to select the appropriate one for a given case.

• How should the Laparoscope be stored to maintain its functionality?

  Storage and handling of the Laparoscope must comply with the manufacturer’s guidelines to preserve its optical clarity and structural integrity. This typically includes keeping it in a clean, dry environment, protected from physical damage, and following any specific storage recommendations provided by Olympus America, Inc. Proper care ensures the device remains effective for its intended use.

• What regulatory pathway was followed for the Laparoscope’s FDA clearance?

  The Laparoscope received FDA 510(k) clearance under product code GCJ through a Traditional review pathway. The determination was made under the Substantially Equivalent classification, meaning it was found to be comparable to a legally marketed predicate device. This clearance allows it to be marketed for its intended diagnostic and surgical uses in minimally invasive procedures.