Cleared Traditional

ELECTROSURGICAL UNIT

K823083 · Kelleher Corp. · General & Plastic Surgery

Dec 1982

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K823083 is an FDA 510(k) clearance for the ELECTROSURGICAL UNIT, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on December 7, 1982, 49 days after receiving the submission on October 19, 1982. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K823083 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 19, 1982
Decision Date	December 07, 1982
Days to Decision	49 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—

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).