KSEA Universal Laparomat Laparoscopic Suction and Irrigation Pump

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

510(k) Number

K010569 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Karl Storz Endoscopy →

• What is the KSEA Universal Laparomat used for?

  The KSEA Universal Laparomat is designed for laparoscopic suction and irrigation during minimally invasive surgical procedures. It helps manage fluids in the abdominal cavity, ensuring clear visualization for surgeons while maintaining sterile conditions. This is particularly useful in specialties like gastroenterology and urology, where precise fluid control is critical to avoid complications and optimize operating conditions.

• Is the KSEA Universal Laparomat a single-use or reusable device?

  The KSEA Universal Laparomat is a reusable medical instrument. It is intended for use in controlled surgical environments such as operating rooms or endoscopy suites, with the requirement for proper sterilization between procedures to uphold hygiene standards. Reusability is supported by its modular design, which allows compatibility with various endoscopic tools and systems.

• How is the KSEA Universal Laparomat sterilized?

  Since the KSEA Universal Laparomat is a reusable device, it must undergo thorough sterilization between uses to prevent contamination and ensure patient safety. The manufacturer recommends following standard sterilization protocols for medical instruments, such as autoclaving or chemical sterilization, to maintain its functionality and hygiene. Always refer to the manufacturer’s instructions for specific sterilization guidelines.

• What regulatory approval does the KSEA Universal Laparomat hold?

  The KSEA Universal Laparomat has received FDA 510(k) clearance under product code GCJ and regulation number 876.1500. This classification confirms it is substantially equivalent to predicate devices, meeting FDA-regulated standards for laparoscopic suction and irrigation pumps. The approval ensures it adheres to safety and performance requirements for use in surgical settings.

• Can the KSEA Universal Laparomat be used with other laparoscopic instruments?

  Yes, the KSEA Universal Laparomat features a modular design that supports compatibility with various laparoscopic instruments and systems. This flexibility allows surgeons to integrate it seamlessly into existing endoscopic workflows, enhancing its versatility for different minimally invasive procedures in gastroenterology and urology.