Cleared Traditional

ELECTROSURGICAL UNIT WITH ACCESSORIES

K905654 · Aspen Labs · General & Plastic Surgery

Mar 1991

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K905654 is an FDA 510(k) clearance for the ELECTROSURGICAL UNIT WITH ACCESSORIES, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Aspen Labs (Englewood, US). The FDA issued a Cleared decision on March 18, 1991, 90 days after receiving the submission on December 18, 1990. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K905654 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 18, 1990
Decision Date	March 18, 1991
Days to Decision	90 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).