Cleared Traditional

DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE

K970993 · Deroyal Industries, Inc. · General & Plastic Surgery

May 1997

Decision

64d

Days

Class 2

Risk

About This 510(k) Submission

K970993 is an FDA 510(k) clearance for the DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Deroyal Industries, Inc. (Knoxville, US). The FDA issued a Cleared decision on May 22, 1997, 64 days after receiving the submission on March 19, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K970993 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 19, 1997
Decision Date	May 22, 1997
Days to Decision	64 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).