Cleared Traditional

LARYNGEAL SPATULAS

K822259 · Kelleher Corp. · Ear, Nose, Throat
Oct 1982
Decision
85d
Days
Class 1
Risk

About This 510(k) Submission

K822259 is an FDA 510(k) clearance for the LARYNGEAL SPATULAS, a Source, Carrier, Fiberoptic Light (Class I — General Controls, product code EQH), submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on October 22, 1982, 85 days after receiving the submission on July 29, 1982. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4350.

Submission Details

510(k) Number K822259 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1982
Decision Date October 22, 1982
Days to Decision 85 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

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