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LevaLap Laparoscopic Access Device

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K212786

by Core Access Surgical Technologies, Inc.

Identifiers

510(k) Number
K212786 FDA 510(k)
FDA Product Code
HIF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.1730 FDA 510(k)
Regulation Number
884.1730 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The LevaLap Laparoscopic Access Device is a Laparoscopic Access Device designed to facilitate trocar insertion and insufflation during minimally invasive surgical procedures. It combines a trocar and insufflation port in a single unit, enabling controlled entry into the abdominal cavity while maintaining pneumoperitoneum for clear visualization and manipulation.

This device is intended for single-use in operating room settings and is classified as a Class II medical device under FDA regulations. It is supplied sterile and requires no additional preparation beyond standard surgical aseptic techniques. The device is MRI-unsafe due to metallic components and must be removed prior to MRI procedures. Authorized under FDA 510(k) clearance and MDR, it adheres to regulatory standards for obstetrics and gynecology applications.

Frequently asked questions

What types of surgical procedures is the LevaLap Laparoscopic Access Device designed to assist with, and why is it particularly useful in those settings?

The LevaLap Laparoscopic Access Device is designed for minimally invasive surgical procedures, specifically within the obstetrics and gynecology specialty. It combines a trocar and insufflation port into one unit, which simplifies the setup by eliminating the need for separate instruments. This design is particularly useful in procedures requiring clear visualization of the abdominal cavity, such as laparoscopic surgeries, where maintaining pneumoperitoneum (controlled gas pressure) is critical for optimal visibility and manipulation.

Is the LevaLap Laparoscopic Access Device reusable, or is it intended for single-use only? How should it be handled to maintain sterility?

The LevaLap Laparoscopic Access Device is intended for single-use only in operating room settings. It is supplied sterile and requires no additional preparation beyond standard surgical aseptic techniques. Since it is designed for one-time use, it should be discarded after a single procedure to ensure patient safety and prevent cross-contamination.

What precautions should be taken if a patient needs an MRI scan after using the LevaLap Laparoscopic Access Device?

The LevaLap Laparoscopic Access Device contains metallic components, which make it MRI-unsafe. If a patient requires an MRI scan following surgery, the device must be fully removed from the body before the procedure. Leaving metallic instruments in place during an MRI can cause heating, distortion of images, or injury to the patient.

Are there different sizes or models of the LevaLap Laparoscopic Access Device, and if so, how are they determined?

The provided data does not specify exact sizes or model variations of the LevaLap Laparoscopic Access Device. However, laparoscopic access devices typically come in different diameters (e.g., 5mm, 10mm, 12mm) to accommodate varying surgical needs. For precise sizing options, refer to the manufacturer’s product catalog or consult with Core Access Surgical Technologies, Inc. The device’s design suggests versatility for standard laparoscopic procedures, but exact configurations would depend on clinical requirements.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Core Access Surgical Technologies, Inc.

Sources (2)

  • FDA 510(k) K212786 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026