Cleared Traditional

EMC MODEL STATOME 200

K952231 · Emc Industries · General & Plastic Surgery

Nov 1995

Decision

193d

Days

Class 2

Risk

About This 510(k) Submission

K952231 is an FDA 510(k) clearance for the EMC MODEL STATOME 200, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Emc Industries (Los Altos, US). The FDA issued a Cleared decision on November 21, 1995, 193 days after receiving the submission on May 12, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K952231 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 12, 1995
Decision Date	November 21, 1995
Days to Decision	193 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).