K964736 · Bergen Mfg. · GEI · Feb 27, 1997 · General, Plastic Surgery
Device Facts
Record ID
K964736
Device Name
BERGEN 610 BIPOLAR COAGULATOR
Applicant
Bergen Mfg.
Product Code
GEI · General, Plastic Surgery
Decision Date
Feb 27, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4400
Device Class
Class 2
Device Story
BERGEN 610 Coagulator; bipolar electrosurgical device. Features 0-50 digital power setting display (+/- 5 watts at 100 ohms); bar graph output current monitor for energy activation status. Handswitch powered by independent 7 Vdc isolated supply. Used by clinicians for coagulation; provides visual/audio monitoring of output. Safety features include RF and low frequency leakage compliance with IEC 601-1-2 and ANSI HF-18 standards for isolated body-floating devices.
Clinical Evidence
No clinical data provided; safety and effectiveness based on compliance with IEC 601-1-2 and ANSI HF-18 standards.
Technological Characteristics
Bipolar coagulator; isolated (body floating) output; 7 Vdc handswitch power supply; digital power display; bar graph current monitor. Compliant with IEC 601-1-2 and ANSI HF-18 safety standards.
Regulatory Classification
Identification
An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
Submission Summary (Full Text)
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U.S. Food and Drug Administration
510K Document Mail Center HFZ-401
Center for Medical Devices
390 Piccard Drive
Rockville, Maryland 20850
November 15, 1996
To: Document Control Clerk
This summary of 510K safety and effectiveness for the BERGEN 610 Coagulator is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807,92.
A 0-50 digital display power setting indicator provides the operator a parallax free reading of the power setting (+/- 5watts, full scale @ 100 ohms).
A bar graph display output current monitor provides the operator a relative measure of the output current amplitude and to denote the presence of output energy during activation.
The handswitch is powered by an independent low voltage (7 Vdc) isolated power supply.
Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines.
RF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines lines for isolated (body floating) bipolar coagulators.
This device is substantially equivalent to existing approved devices.
Sincerely,
Roger Oosten
Bergen Mfg
9345 Rookery Road
New Port Richey, Florida 34654
Date 11/15/96
