Cleared Traditional

OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE

K971166 · Richard Wolf Medical Instruments Corp. · Ear, Nose, Throat

Aug 1997

Decision

149d

Days

Class 2

Risk

About This 510(k) Submission

K971166 is an FDA 510(k) clearance for the OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE, a Mediastinoscope, Surgical (Class II — Special Controls, product code EWY), submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on August 27, 1997, 149 days after receiving the submission on March 31, 1997. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4720.

Submission Details

510(k) Number	K971166 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 1997
Decision Date	August 27, 1997
Days to Decision	149 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	EWY — Mediastinoscope, Surgical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4720
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).