Bergen 710 Esu

FDA 510(k) K945861 · Bergen Mfg.

Substantially Equivalent

510(k) numberK945861

Submission

Device name
Bergen 710 Esu
Applicant
Bergen Mfg.
New Port Richey, FL, US
Received
December 1, 1994
Decision date
March 1, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

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

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K993306Nikopad Electrosurgical Grounding Pad (*Or Sold Under Commercial Names), Model 4760…HAM · Special Paladin Medical, Inc.11/03/1999SE
K913300Laparostat(Tm)HAM · Traditional Cook Ob/Gyn04/02/1992SE
K920100Gsu Handpiece AdapterHAM · Traditional Beacon Laboratories, Inc.02/03/1992SE
K911353Emc Model No. Statome 900HAM · Traditional Emc Industries06/24/1991SE
K901248Abc Handpiece AdapterHAM · Traditional Beacon Laboratories, Inc.04/03/1990SE
K881334Light Coagulator LC 250HAM · Traditional Nk-Optik GmbH11/16/1989SE
K895337Electrosurgical Coagulation Suction TubeHAM · Traditional New England Surgical Instrument Corp.09/15/1989SE
K894762B100 Disposable HandpieceHAM · Traditional Beacon Laboratories, Inc.09/15/1989SE

More from Beacon Laboratories, Inc.

510(k)DeviceDecision
K972299Bergen Model 500 Electrosurgery GeneratorGEI · Traditional 08/27/1997SE
K964736Bergen 610 Bipolar CoagulatorGEI · Traditional 02/27/1997SE
K863701Model 709 Bipolar Micro CoagulatorGEI · Traditional 10/14/1986SE

Questions and answers

When was Bergen 710 Esu cleared by the FDA?

Bergen 710 Esu (K945861) received a 510(k) decision of Substantially Equivalent on March 1, 1995, 90 days after the submission was received.

What is the product code of K945861?

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