Cleared Special

CSS

K031564 · Medical Scientific, Inc. · General & Plastic Surgery

Oct 2003

Decision

141d

Days

Class 2

Risk

About This 510(k) Submission

K031564 is an FDA 510(k) clearance for the CSS, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Medical Scientific, Inc. (Taunton, US). The FDA issued a Cleared decision on October 7, 2003, 141 days after receiving the submission on May 19, 2003. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K031564 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 19, 2003
Decision Date	October 07, 2003
Days to Decision	141 days
Submission Type	Special
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).