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AP50/30 Insufflator with Insuflow Port

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191780

by Lexion Medical LLC

Identifiers

510(k) Number
K191780 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 AP50/30 Insufflator with Insuflow Port is a carbon dioxide insufflator and pneumo-management system designed for laparoscopic and robotic surgery. It utilizes real-time pressure and flow sensing technology to deliver a stable pneumoperitoneum during minimally invasive procedures.

The Insuflow Port is a gas conditioning and access port device that attaches to the insufflator to warm and humidify the carbon dioxide gas stream prior to entry. This system is available in 5, 8, 10, and 12 mm sizes and is authorized under FDA 510K clearance.

Frequently asked questions

What is the primary function of the AP50/30 Insufflator?

The AP50/30 is a carbon dioxide insufflator and pneumo-management system designed to maintain a stable pneumoperitoneum during robotic and laparoscopic surgical procedures using real-time pressure and flow sensing technology.

How does the Insuflow Port enhance the insufflation process?

The Insuflow Port acts as a gas conditioning and access device that attaches to the insufflator. It is designed to warm and humidify the carbon dioxide gas stream before it enters the patient to support pneumo-management.

What size options are available for this system?

The system is available in four distinct sizes, including 5 mm, 8 mm, 10 mm, and 12 mm, to accommodate different surgical access requirements.

What is the regulatory status of this device?

The AP50/30 Insufflator with Insuflow Port is authorized under FDA 510K clearance, which indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

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. Sources consulted: LEXION Medical, Pneumostability — Lexion Medical, PDF LEXION Medical LLC ℅ Bernard Horwath Regulatory Consultant HRG 4486 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Lexion Medical LLC
FDA Applicant
Lexion Medical, LLC

Sources (1)

  • FDA 510(k) K191780 24 fields · synced Sep 21, 2026