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Excel Duopaulse Model 2000

by Excel Tech., Ltd. 510(k)

Active United States

510(k) K915679

Overview

The Excel Duopaulse Model 2000 is a medical device identified under product code GEX. It is designed for use within the field of general and plastic surgery.

This device received FDA 510(k) clearance on June 24, 1992, under submission number K915679. It is manufactured by Excel Tech., Ltd., based in Holbrook, New York.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK915679 Date24 Jun 1992ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GEX
FDA applicant
Excel Tech. , Ltd.
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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