Cleared Traditional

EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES

K062171 · Ortho Development Corp. · General & Plastic Surgery

May 2007

Decision

298d

Days

Class 2

Risk

About This 510(k) Submission

K062171 is an FDA 510(k) clearance for the EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on May 25, 2007, 298 days after receiving the submission on July 31, 2006. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K062171 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2006
Decision Date	May 25, 2007
Days to Decision	298 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement

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).