About This 510(k) Submission
K982965 is an FDA 510(k) clearance for the ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES, a Camera, Television, Endoscopic, Without Audio (Class I — General Controls, product code FWF), submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on November 23, 1998, 90 days after receiving the submission on August 25, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4160.