Cleared Traditional

BERGEN MODEL 500 ELECTROSURGERY GENERATOR

K972299 · Bergen Mfg. · General & Plastic Surgery

Aug 1997

Decision

69d

Days

Class 2

Risk

About This 510(k) Submission

K972299 is an FDA 510(k) clearance for the BERGEN MODEL 500 ELECTROSURGERY GENERATOR, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Bergen Mfg. (New Port Richey, US). The FDA issued a Cleared decision on August 27, 1997, 69 days after receiving the submission on June 19, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K972299 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 19, 1997
Decision Date	August 27, 1997
Days to Decision	69 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4400
Definition	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).