Cleared Traditional

MF-450 ELECTROSURGICAL UNIT 60-5500-001

K896839 · Aspen Laboratories, Inc. · General & Plastic Surgery

Feb 1990

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K896839 is an FDA 510(k) clearance for the MF-450 ELECTROSURGICAL UNIT 60-5500-001, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Aspen Laboratories, Inc. (Littleton, US). The FDA issued a Cleared decision on February 2, 1990, 59 days after receiving the submission on December 5, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K896839 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 05, 1989
Decision Date	February 02, 1990
Days to Decision	59 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).