Cleared Traditional

SINGLE USE ARTHROSCOPY ELECTRODE

K852355 · Aspen Laboratories, Inc. · General & Plastic Surgery

Sep 1985

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K852355 is an FDA 510(k) clearance for the SINGLE USE ARTHROSCOPY ELECTRODE, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Aspen Laboratories, Inc. (Englewood, US). The FDA issued a Cleared decision on September 3, 1985, 92 days after receiving the submission on June 3, 1985. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K852355 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 1985
Decision Date	September 03, 1985
Days to Decision	92 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).