FDA 510(k) Applications Submitted by Digish Mehta
| 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. |
| K220730 |
03/14/2022 |
allFlex Ureteral Catheters, Krait Ureteral Catheters |
Allwin Medical Devices, Inc |
| K220781 |
03/17/2022 |
ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter |
Allwin Medical Devices, Inc |
| K203626 |
12/11/2020 |
SureStrip Vitrification Straw, SureLock Vitrification Straw |
Allwin Medical Devices, Inc |
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