Cleared Traditional

DISPOSABLE ENDOILLUMINATOR

K923774 · O.R. Specialties, Inc. · Ear, Nose, Throat
Oct 1992
Decision
83d
Days
Class 1
Risk

About This 510(k) Submission

K923774 is an FDA 510(k) clearance for the DISPOSABLE ENDOILLUMINATOR, a Source, Carrier, Fiberoptic Light (Class I — General Controls, product code EQH), submitted by O.R. Specialties, Inc. (Tuscaloosa, US). The FDA issued a Cleared decision on October 19, 1992, 83 days after receiving the submission on July 28, 1992. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4350.

Submission Details

510(k) Number K923774 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 1992
Decision Date October 19, 1992
Days to Decision 83 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code EQH — Source, Carrier, Fiberoptic Light
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4350

Similar Devices — EQH Source, Carrier, Fiberoptic Light

All 48
WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT
K945876 · Wells Johnson Co. · Dec 1995
JED-LIGHT FIBEROPTIC LIGHT SOURCE
K954184 · Jedmed Instrument Co. · Nov 1995
COLD LIGHT SOURCE LOS 150
K951829 · Laser Optik Systeme GmbH & Co. KG · Jul 1995
BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE
K932771 · Xomed-Treace, Inc. · Aug 1994
GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT
K941661 · Gm Engineering, Inc. · Aug 1994
GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT
K941662 · Gm Engineering, Inc. · Jul 1994