Cleared Traditional

BEAMER PLUS

K953081 · Aspen Laboratories, Inc. · General & Plastic Surgery

Oct 1995

Decision

119d

Days

Class 2

Risk

About This 510(k) Submission

K953081 is an FDA 510(k) clearance for the BEAMER PLUS, 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 October 30, 1995, 119 days after receiving the submission on July 3, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K953081 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 1995
Decision Date	October 30, 1995
Days to Decision	119 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).