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GelPort Single Incision Access System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K090275

by Applied Medical Resources Corp.

Identifiers

510(k) Number
K090275 FDA 510(k)
FDA Product Code
GCJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The GelPort Single Incision Access System is a laparoscopic device designed to facilitate minimally invasive surgical procedures. It allows surgeons to alternate between hand access, straight laparoscopic techniques, and open surgical approaches during an operation.

This system includes a GelSeal cap for access and an Alexis wound protector-retractor for atraumatic tissue retraction and protection. The device is authorized under FDA 510k clearance K090275.

Frequently asked questions

What is the primary function of the GelPort Single Incision Access System?

The GelPort system is designed to facilitate minimally invasive laparoscopic procedures. It provides the flexibility for surgeons to transition between hand access, straight laparoscopic techniques, and open surgical approaches during a single operation.

What components are included in the GelPort system?

The system consists of two main components: a GelSeal cap, which provides the access point, and an Alexis wound protector-retractor, which is used for atraumatic tissue retraction and protection during the surgical procedure.

What is the regulatory status of this device?

The GelPort Single Incision Access System is authorized under FDA 510k clearance, specifically identified by K-number K090275. This indicates 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: GelPort Hand Access Laparoscopic System | Applied Medical, GelPort Hand Access Laparoscopic System | Applied Medical, GelPOINT Access Platforms | Applied Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Applied Medical Resources Corp.

Sources (1)

  • FDA 510(k) K090275 24 fields · synced Sep 24, 2026