About This 510(k) Submission
K023379 is an FDA 510(k) clearance for the COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER, a Catheter, Assisted Reproduction (Class II — Special Controls, product code MQF), submitted by Cooper Surgical (Huntington, US). The FDA issued a Cleared decision on December 11, 2002, 64 days after receiving the submission on October 8, 2002. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6110.