Cleared Traditional

HM-88011 SOLID STATE ELECTR SURGICAL UNIT

K961473 · Hill-Med, Inc. · General & Plastic Surgery

May 1996

Decision

20d

Days

Class 2

Risk

About This 510(k) Submission

K961473 is an FDA 510(k) clearance for the HM-88011 SOLID STATE ELECTR SURGICAL 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 May 7, 1996, 20 days after receiving the submission on April 17, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K961473 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 17, 1996
Decision Date	May 07, 1996
Days to Decision	20 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).