Cleared Traditional

ELECTROSURGICAL UNIT

K981781 · Hill-Med, Inc. · General & Plastic Surgery

Dec 1998

Decision

198d

Days

Class 2

Risk

About This 510(k) Submission

K981781 is an FDA 510(k) clearance for the ELECTROSURGICAL UNIT, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Hill-Med, Inc. (Miami, US). The FDA issued a Cleared decision on December 4, 1998, 198 days after receiving the submission on May 20, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K981781 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 20, 1998
Decision Date	December 04, 1998
Days to Decision	198 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).