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Port Access System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K210495

by Surgical Innovations Limited

Identifiers

510(k) Number
K210495 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 Port Access System is a minimally invasive surgical device classified under the nomenclature for general and plastic surgery port access systems. It facilitates controlled access to internal body cavities during laparoscopic or endoscopic procedures by providing a sealed entry point for instruments and insufflation gases, reducing contamination risk and improving surgical precision.

This system is designed for single-use in sterile operating environments and is intended for use in minimally invasive surgical settings. It is supplied sterile, packaged individually, and requires no additional preparation beyond standard surgical aseptic techniques. The device complies with FDA 510(k) clearance (K210495) under the Traditional pathway and is categorized under product code GCJ. No MRI safety information or reusable variants are specified in the regulatory data.

Frequently asked questions

What is the Port Access System designed for?

The Port Access System is specifically designed for use in minimally invasive surgical procedures, such as laparoscopy or endoscopy. It provides a sealed entry point into internal body cavities, allowing controlled access for surgical instruments and insufflation gases. This design helps minimize contamination risk and improves precision during procedures, making it ideal for general and plastic surgery applications.

How is the Port Access System supplied and prepared for use?

The Port Access System is supplied sterile, individually packaged, and ready for immediate use in sterile operating environments. No additional preparation is required beyond adhering to standard surgical aseptic techniques. This ensures readiness for single-use applications without extra handling or sterilization steps.

Is the Port Access System intended for single-use or reuse?

The Port Access System is explicitly designed for single-use only. This design choice aligns with best practices for maintaining sterility and reducing infection risks in surgical settings. Reuse is not recommended or supported by the manufacturer.

What regulatory pathway does the Port Access System follow?

The Port Access System has received FDA 510(k) clearance under the Traditional pathway, with clearance number K210495. This classification confirms that the device is deemed substantially equivalent to a legally marketed predicate device, ensuring compliance with U.S. regulatory standards for minimally invasive surgical tools.

Does the Port Access System include any MRI safety information?

The regulatory data for the Port Access System does not specify any MRI safety information. Clinicians should consult additional manufacturer documentation or guidelines if MRI compatibility is a concern for their specific use case, as this device is not explicitly labeled for MRI environments.

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: YelloPort+ TM - Surgical Innovations Limited, Surgical Innovations Limited - Transforming Surgery Together, K210495 FDA 510 (k) - Port Access System

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Surgical Innovations Limited

Sources (1)

  • FDA 510(k) K210495 24 fields · synced Oct 5, 2026