FDA 510(k) Applications Submitted by Allwin Medical Devices, Inc.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K200248 |
01/31/2020 |
Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators |
Allwin Medical Devices, Inc. |
K190522 |
03/04/2019 |
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 an |
Allwin Medical Devices, Inc. |
K190590 |
03/07/2019 |
Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle) |
Allwin Medical Devices, Inc. |
K190659 |
03/14/2019 |
Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Cl |
Allwin Medical Devices, Inc. |
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