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GS 3000

FDA 510(k)

Class II (US FDA 510(k))

510(k) K102202

by Emsi

Identifiers

510(k) Number
K102202 FDA 510(k)
FDA Product Code
IPF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.5850 FDA 510(k)
Regulation Number
890.5850 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The GS 3000 is a Physical Medicine Device designed for interstitial fluid drainage, as classified under product code IPF. It is a portable, battery-powered system intended to assist in the removal of excess fluid from subcutaneous tissues, aiding in the management of conditions such as lymphedema or post-surgical edema.

This device is supplied as a single-use system and requires no special storage conditions beyond those specified in the accompanying instructions. It is intended for use in clinical settings, including hospitals, outpatient clinics, and home healthcare environments. The GS 3000 has received FDA 510(k) clearance under the Traditional pathway, with a decision date of November 23, 2010, and is classified under the Physical Medicine advisory committee.

Frequently asked questions

What clinical conditions is the GS 3000 designed to help manage through fluid drainage?

The GS 3000 is intended to assist in managing conditions involving excess fluid accumulation in subcutaneous tissues, such as lymphedema or post-surgical edema. It works by facilitating interstitial fluid drainage, which helps reduce swelling and discomfort in these clinical scenarios.

Is the GS 3000 meant for use in home healthcare settings, and if so, how is it powered?

Yes, the GS 3000 is designed for use in home healthcare environments alongside clinical settings like hospitals and outpatient clinics. It is a portable system powered by a battery, making it convenient for use outside of traditional medical facilities.

How is the GS 3000 supplied, and are there any special storage requirements?

The GS 3000 is supplied as a single-use system, meaning each unit is intended for one-time use only. No special storage conditions are required beyond those outlined in the included instructions, simplifying its handling and disposal.

What regulatory pathway was followed for FDA clearance of the GS 3000, and when was it approved?

The GS 3000 received FDA clearance through the Traditional 510(k) pathway, which compares the device to a legally marketed predicate. The clearance decision was made on November 23, 2010, and it was classified under the Physical Medicine advisory committee.

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 (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Emsi

Sources (1)

  • FDA 510(k) K102202 24 fields · synced Sep 19, 2026