Cleared Traditional

K101158 - LIC INSTRUMENT PROCESSING SYSTEM
(FDA 510(k) Clearance)

K101158 · Langford IC Systems, Inc. · General Hospital

May 2011

Decision

375d

Days

Class 2

Risk

K101158 is an FDA 510(k) clearance for the LIC INSTRUMENT PROCESSING SYSTEM, a Accessories, Cleaning, For Endoscope (Class II — Special Controls, product code FEB), submitted by Langford IC Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on May 6, 2011, 375 days after receiving the submission on April 26, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K101158 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 26, 2010
Decision Date	May 06, 2011
Days to Decision	375 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FEB — Accessories, Cleaning, For Endoscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).