Cleared Traditional

INSURGICAL SINGLE USE POWER EQUIPMENT

K112599 · Insurgical, LLC · Orthopedic

Nov 2012

Decision

426d

Days

Class 1

Risk

About This 510(k) Submission

K112599 is an FDA 510(k) clearance for the INSURGICAL SINGLE USE POWER EQUIPMENT, a Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment (Class I — General Controls, product code KIJ), submitted by Insurgical, LLC (Austin, US). The FDA issued a Cleared decision on November 6, 2012, 426 days after receiving the submission on September 7, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K112599 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 07, 2011
Decision Date	November 06, 2012
Days to Decision	426 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KIJ — Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4820