Disposable Electrosurgery Ball Electrode

FDA 510(k) K925708 · Beacon Laboratories, Inc.

Substantially Equivalent

510(k) numberK925708

Submission

Device name
Disposable Electrosurgery Ball Electrode
Applicant
Beacon Laboratories, Inc.
Broomfield, CO, US
Received
November 12, 1992
Decision date
April 20, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DWG – Electrosurgical Device
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4400
Specialty
General, Plastic Surgery

Other 510(k)s with product code DWG

510(k)DeviceApplicantDecision
K942823Mahe InstrumentsDWG · Traditional Mahe Intl., Inc.12/05/1994SE
K932345Tech-Switch Electrosurgical Pencil, Single UseDWG · Traditional Conmedcorp04/12/1994SE
K931215Hand-Trol SDWG · Traditional Aspen Labs03/28/1994SE

More from Aspen Labs

510(k)DeviceDecision
K930243Flexible ExtenderGEI · Traditional 03/11/1994SE
K930497Argon HandpiecesGEI · Traditional 06/25/1993SE
K922289Sesquipolar(Tm) Mis ElectrodeGEI · Traditional 01/15/1993SE
K925619Disposable Hand-Switching Esu PencilGEI · Traditional 12/24/1992SE
K915788Mis Electrosurgical ElectrodesGEI · Traditional 03/13/1992SE
K920100Gsu Handpiece AdapterHAM · Traditional 02/03/1992SE
K913772Pressure GuardHIF · Traditional 11/19/1991SE
K905752Argon Beam Combo Laparoscopic ElectrodeGEI · Traditional 07/22/1991SE
K904506Active AdapterGEI · Traditional 12/13/1990SE
K902996Argon Beam Laparoscopic ElectrodeGEI · Traditional 11/21/1990SE

Questions and answers

When was Disposable Electrosurgery Ball Electrode cleared by the FDA?

Disposable Electrosurgery Ball Electrode (K925708) received a 510(k) decision of Substantially Equivalent on April 20, 1993, 159 days after the submission was received.

What is the product code of K925708?

The FDA product code is DWG – Electrosurgical Device, a Class II (moderate risk) device regulated under 21 CFR 878.4400.