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SI Controller Model SI 500

FDA 510(k)

Class II (US FDA 510(k))

510(k) K960492

by I.C. Medical, Inc.

Identifiers

510(k) Number
K960492 FDA 510(k)
FDA Product Code
BTA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4780 FDA 510(k)
Regulation Number
878.4780 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SI Controller Model SI 500 is a portable pump for aspiration (manual or powered) used to control the flow of irrigation fluids and vacuum to suction/irrigation and multifunction accessories with compatible suction/irrigation features. It is intended for use during wound care and open and closed surgical procedures, and when used with appropriate accessories, may be used for hydro-dissection.

The device is supplied as a reusable controller and is regulated under FDA 510(k) clearance K960492, with device class 2, product code BTA, and regulation number 878.4780. It was determined to be substantially equivalent to a predicate device, with a traditional clearance type, and is indicated for general and plastic surgery specialties.

Frequently asked questions

What is the SI Controller Model SI 500 used for?

The SI Controller Model SI 500 is a portable pump designed for aspiration (manual or powered) to control the flow of irrigation fluids and vacuum. It is used with compatible suction/irrigation and multifunction accessories during wound care, open and closed surgical procedures, and hydro-dissection when appropriate accessories are attached.

Is the SI Controller Model SI 500 reusable or single-use?

The SI Controller Model SI 500 is supplied as a reusable controller, meaning it is designed for multiple uses after proper cleaning and disinfection between procedures, in accordance with the manufacturer's instructions for use.

What regulatory pathway was used for the SI Controller Model SI 500?

The SI Controller Model SI 500 received FDA 510(k) clearance under K960492, determined to be substantially equivalent to a predicate device through a traditional clearance process, and is classified as a Class II medical device with product code BTA.

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: SI CONTROLLER MODEL SI 500 (K960492) — FDA 510(k) | Innolitics, K960492 FDA 510 (k) - SI CONTROLLER MODEL SI 500, Si Controller Model Si 500 - Beudamed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
I.C. Medical, Inc.
FDA Applicant
I.C Medical, Inc.

Sources (1)

  • FDA 510(k) K960492 24 fields · synced Sep 26, 2026