Cleared Traditional

WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT

K951519 · Wells Johnson Co. · General & Plastic Surgery
Jun 1995
Decision
72d
Days
Class 1
Risk

About This 510(k) Submission

K951519 is an FDA 510(k) clearance for the WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT, a Camera, Cine, Endoscopic, Without Audio (Class I — General Controls, product code FWL), submitted by Wells Johnson Co. (Tucson, US). The FDA issued a Cleared decision on June 14, 1995, 72 days after receiving the submission on April 3, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4160.

Submission Details

510(k) Number K951519 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 1995
Decision Date June 14, 1995
Days to Decision 72 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code FWL — Camera, Cine, Endoscopic, Without Audio
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4160