Cleared Traditional

WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT

K945876 · Wells Johnson Co. · Ear, Nose, Throat
Dec 1995
Decision
368d
Days
Class 1
Risk

About This 510(k) Submission

K945876 is an FDA 510(k) clearance for the WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT, a Source, Carrier, Fiberoptic Light (Class I — General Controls, product code EQH), submitted by Wells Johnson Co. (Tucson, US). The FDA issued a Cleared decision on December 4, 1995, 368 days after receiving the submission on December 1, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4350.

Submission Details

510(k) Number K945876 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 1994
Decision Date December 04, 1995
Days to Decision 368 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
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
SAPHIRE PLUS SURGICAL MIRROR
K934911 · San Diego Swiss Machining, Inc. · Jun 1994