Cleared Traditional

VIDEO SCOPE SYSTEM (LARYNGOSCOPE)

K944032 · Jedmed Instrument Co. · Ear, Nose, Throat

Sep 1995

Decision

394d

Days

Class 2

Risk

About This 510(k) Submission

K944032 is an FDA 510(k) clearance for the VIDEO SCOPE SYSTEM (LARYNGOSCOPE), a Telescope, Laryngeal-bronchial (Class II — Special Controls, product code ENZ), submitted by Jedmed Instrument Co. (St.Louis, US). The FDA issued a Cleared decision on September 15, 1995, 394 days after receiving the submission on August 17, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K944032 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 17, 1994
Decision Date	September 15, 1995
Days to Decision	394 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement

Device Classification

Product Code	ENZ — Telescope, Laryngeal-bronchial
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4680
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).