Cleared Traditional

VALLEYLAB COATED ELECTRODES

K962044 · Valleylab, Inc. · General & Plastic Surgery

Aug 1996

Decision

94d

Days

Class 2

Risk

About This 510(k) Submission

K962044 is an FDA 510(k) clearance for the VALLEYLAB COATED ELECTRODES, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Valleylab, Inc. (Boulder, US). The FDA issued a Cleared decision on August 30, 1996, 94 days after receiving the submission on May 28, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K962044 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 28, 1996
Decision Date	August 30, 1996
Days to Decision	94 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

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).