Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)

About This 510(k) Submission

K190522 is an FDA 510(k) clearance for the Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter), a Catheter, Assisted Reproduction (Class II — Special Controls, product code MQF), submitted by Allwin Medical Devices, Inc. (Anaheim, US). The FDA issued a Cleared decision on November 14, 2019, 255 days after receiving the submission on March 4, 2019. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6110.