Cleared Traditional

MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019

K061135 · Aesculap · Neurology

Jul 2006

Decision

78d

Days

Class 2

Risk

About This 510(k) Submission

K061135 is an FDA 510(k) clearance for the MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019, a Endoscope, Neurological (Class II — Special Controls, product code GWG), submitted by Aesculap (Harleysville, US). The FDA issued a Cleared decision on July 11, 2006, 78 days after receiving the submission on April 24, 2006. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1480.

Submission Details

510(k) Number	K061135 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 24, 2006
Decision Date	July 11, 2006
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	GWG — Endoscope, Neurological
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1480
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).