Bergen 610 Bipolar Coagulator

Q: What is the product code of K964736?

The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.

FDA 510(k) K964736 · Bergen Mfg.

Substantially Equivalent

510(k) numberK964736

Submission

Device name: Bergen 610 Bipolar Coagulator
Applicant: Bergen Mfg.
New Port Richey, FL, US
Received: November 25, 1996
Decision date: February 27, 1997
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GEI – Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.4400
Specialty: General, Plastic Surgery

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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K972299	Bergen Model 500 Electrosurgery GeneratorGEI · Traditional	08/27/1997SE
K945861	Bergen 710 EsuHAM · Traditional	03/01/1995SE
K863701	Model 709 Bipolar Micro CoagulatorGEI · Traditional	10/14/1986SE

Questions and answers

When was Bergen 610 Bipolar Coagulator cleared by the FDA?

Bergen 610 Bipolar Coagulator (K964736) received a 510(k) decision of Substantially Equivalent on February 27, 1997, 94 days after the submission was received.

What is the product code of K964736?

The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.