Weco Endoscopic System with Fiber Optic Light

FDA 510(k) K951519 · Wells Johnson Co.

Substantially Equivalent

510(k) numberK951519

Submission

Device name
Weco Endoscopic System with Fiber Optic Light
Applicant
Wells Johnson Co.
Tucson, AZ, US
Received
April 3, 1995
Decision date
June 14, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FWL – Camera, Cine, Endoscopic, Without Audio
Device class
Class I (low risk)
Regulation
21 CFR 878.4160
Specialty
General, Plastic Surgery

Other 510(k)s with product code FWL

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Questions and answers

When was Weco Endoscopic System with Fiber Optic Light cleared by the FDA?

Weco Endoscopic System with Fiber Optic Light (K951519) received a 510(k) decision of Substantially Equivalent on June 14, 1995, 72 days after the submission was received.

What is the product code of K951519?

The FDA product code is FWL – Camera, Cine, Endoscopic, Without Audio, a Class I (low risk) device regulated under 21 CFR 878.4160.