Laparoscopic Trocar

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

510(k) Number

K953409 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Core Dynamics Laparoscipic Irrigation Pump

  Class II

  FDA 510(k) K931138 Active Cleared 7 Sep 1993

• Core Disposable Insufflation Tubing

  Class II

  FDA 510(k) K901413 Active Cleared 24 Sep 1990

• Laparoscopic/Suction/Irrigation Probe

  Class II

  FDA 510(k) K935826 Active Cleared 18 May 1994

• Entree Thoracoscopy Cannula Set

  Class II

  FDA 510(k) K932022 Active Cleared 28 Jul 1993

• Laparoscopic Knitter

  Class II

  FDA 510(k) K955490 Active Cleared 22 Jan 1996

• Entree Cannula Fascia Anchors

  Class I

  FDA 510(k) K932021 Active Cleared 11 Jan 1994

See all devices from Core Dynamics, Inc. →

• What is the primary purpose of the Core Dynamics Laparoscopic Trocar?

  The Core Dynamics Laparoscopic Trocar is designed to create controlled access ports in the abdominal wall during minimally invasive surgical procedures. It provides a pathway for inserting laparoscopic instruments and cameras, minimizing trauma to surrounding tissues. This is particularly useful in general surgery, gynecology, and urology to support endoscopic interventions.

• Is the Laparoscopic Trocar reusable or single-use?

  The Laparoscopic Trocar is supplied as a reusable surgical instrument. It is intended for use in sterile operating room environments, meaning it must be properly cleaned, sterilized, and maintained between procedures to ensure safety and functionality.

• What sizes are available for the Core Dynamics Laparoscopic Trocar?

  The device is documented in sizes of 5mm, 10/11mm, and 10/12mm. These sizes accommodate different procedural needs and instrument diameters, allowing clinicians to select the appropriate trocar based on the specific surgical requirements.

• How should the Laparoscopic Trocar be stored and handled?

  Storage and handling must comply with standard surgical instrument protocols to maintain sterility and functionality. This includes proper cleaning, sterilization, and storage in a clean, dry environment to prevent contamination and ensure readiness for reuse.

• Does the Laparoscopic Trocar include an obturator, and what is its role?

  Yes, the Laparoscopic Trocar includes an obturator, which is used for initial insertion through the abdominal wall. Once the trocar is properly seated, the obturator is removed to allow the passage of laparoscopic instruments and cameras through the trocar.