Laproscopic/Endoscopic Surgical Instruments

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

510(k) Number

K925499 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Are these instruments meant for single-use or can they be reused after proper cleaning and sterilization?

  These laparoscopic and endoscopic surgical instruments are designed for reuse only. Since they fall under FDA product code GCJ and are classified as reusable medical devices, they must undergo established decontamination protocols—including cleaning, disinfection, and sterilization—to maintain safety and functionality between uses. The manufacturer, Lapsurg of America, does not specify single-use, and the FDA clearance (K925499) explicitly supports their reusable application in sterile surgical environments.

• What specialties are these instruments primarily intended for, and what types of procedures might they be used in?

  These instruments are primarily intended for use in gastroenterology and urology, as indicated by the Gastroenterology and Urology advisory committee involved in their FDA review. They support minimally invasive procedures in the gastrointestinal and urological systems, such as accessing, visualizing, and manipulating tissues through small incisions or natural orifices. This includes diagnostic and therapeutic interventions like biopsies, tissue removal, or suturing, but the advisory committee designation does not define clinical indications—only the procedural context.

• How should these instruments be stored to ensure they remain safe and functional for reuse?

  Since these instruments are reusable, proper storage is critical to prevent damage or contamination. While the data does not specify exact storage conditions, reusable surgical instruments generally require clean, dry, and protected environments—such as sterile packaging or designated instrument trays—when not in use. They should be stored in a way that avoids exposure to moisture, sharp objects, or extreme temperatures, as these can compromise their integrity before sterilization. Always follow the manufacturer’s decontamination protocols for optimal longevity.

• What does the FDA clearance (K925499) mean for the clinical use of these instruments, and when was the decision made?

  The FDA clearance (K925499) under the Traditional 510(k) review pathway indicates that Lapsurg of America’s laparoscopic/endoscopic instruments were deemed substantially equivalent (SESE) to a legally marketed predicate device in 1994. This means the FDA determined they have the same intended purpose and technological characteristics as the predicate, ensuring they meet regulatory standards for safety and effectiveness. The decision date was February 18, 1994, and the clearance was filed under product code GCJ for reusable surgical instruments in sterile environments.

• Are there any special considerations for using these instruments in patients who may require MRI scans afterward?

  The provided regulatory data does not explicitly state whether these instruments are MRI-safe. Since they are reusable laparoscopic/endoscopic tools, their material composition (e.g., metals, plastics) could influence MRI compatibility. If MRI scans are planned post-procedure, clinicians should verify with the manufacturer or consult MRI safety guidelines to ensure no ferromagnetic or non-MRI-compatible components remain in the patient. Always confirm compatibility before use in an MRI environment.