Cleared Traditional

GRIESHABER THREE FUNCTION MANIPULATOR

K914586 · Grieshaber & Co. · Ear, Nose, Throat
Jan 1992
Decision
79d
Days
Class 1
Risk

About This 510(k) Submission

K914586 is an FDA 510(k) clearance for the GRIESHABER THREE FUNCTION MANIPULATOR, a Source, Carrier, Fiberoptic Light (Class I — General Controls, product code EQH), submitted by Grieshaber & Co. (Langhorne, US). The FDA issued a Cleared decision on January 3, 1992, 79 days after receiving the submission on October 16, 1991. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4350.

Submission Details

510(k) Number K914586 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 1991
Decision Date January 03, 1992
Days to Decision 79 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