Cleared Traditional

SYSTEM 7500 ABC ELECTROSURGICAL UNIT

K981220 · Aspen Laboratories, Inc. · General & Plastic Surgery

Apr 1998

Decision

18d

Days

Class 2

Risk

About This 510(k) Submission

K981220 is an FDA 510(k) clearance for the SYSTEM 7500 ABC ELECTROSURGICAL UNIT, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Aspen Laboratories, Inc. (Centennial, US). The FDA issued a Cleared decision on April 21, 1998, 18 days after receiving the submission on April 3, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K981220 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 03, 1998
Decision Date	April 21, 1998
Days to Decision	18 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).