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GS 3000

by Emsi

510(k) K102202

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK102202 Date23 Nov 2010ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
IPF
Device class
Class II
Regulation
21 CFR Part 890.5850
Advisory committee
Physical Medicine
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

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