Trocar With Shield

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

510(k) Number

K942819 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Forceps, Biopsy Gynecological Instru/Biopsy

  Class I

  FDA 510(k) K933767 Active Cleared 26 May 1994

• Mahe Instruments

  Class II

  FDA 510(k) K935442 Active Cleared 14 Mar 1994

• Microsurgical Instruments

  Class II

  FDA 510(k) K925624 Active Cleared 22 Jul 1993

• Punch Surgical

  Class I

  FDA 510(k) K933772 Active Cleared 1 Feb 1994

• Coagulator, Laparoscopic, Lunipolar/Accessories

  Class II

  FDA 510(k) K933768 Active Cleared 27 Jun 1994

• Forceps, ENT Instr, ENT Manual Surg Retract/All Type

  Class I

  FDA 510(k) K933770 Active Cleared 23 Mar 1994

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• What types of surgical procedures is this trocar with shield primarily used for, and why is the protective shield important?

  This trocar with shield is designed for minimally invasive procedures in general and plastic surgery, commonly used in settings like gastroenterology and urology. The protective shield is crucial because it reduces the risk of injury during insertion, ensuring safer entry into body cavities during laparoscopic or endoscopic surgeries. Its design helps minimize potential harm to internal organs or tissues during the initial puncture phase.

• Is this trocar intended for single-use or reusable applications, and what does that mean for sterilization?

  This trocar with shield is explicitly intended for single-use only. Since it is supplied sterile, this means it should not be reused after a single surgical procedure. Reusing a single-use device could compromise sterility and patient safety, so adherence to single-use protocols is essential to maintain proper surgical hygiene and infection control.

• How is this device regulated, and what does the FDA’s product code GCJ indicate about its classification?

  This trocar with shield is regulated under the FDA’s 510(k) clearance process, specifically under clearance number K942819, granted on August 23, 1994. The product code GCJ classifies it as a laparoscope-related device, meaning it falls under the broader category of instruments used for minimally invasive abdominal or thoracic surgeries. The clearance indicates it is deemed substantially equivalent to a legally marketed device, ensuring it meets FDA safety and performance standards.

• What should I consider when storing this trocar with shield to maintain its integrity?

  Since this trocar is supplied sterile, it should be stored in its original, unopened packaging until ready for use to preserve sterility. The packaging is likely designed to protect against contamination, moisture, and physical damage. Always follow manufacturer guidelines for storage conditions, such as avoiding extreme temperatures or direct sunlight, to ensure the device remains safe and effective for its intended single-use procedure.