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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Catheter, Ureteral
510(k) Number K220781
Device Name 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
Applicant
Allwin Medical Devices, Inc.
3305 E. Mira Loma Ave., Suite 176
Anaheim,  CA  92806
Applicant Contact Digish Mehta
Correspondent
Allwin Medical Devices, Inc.
3305 E. Mira Loma Ave., Suite 176
Anaheim,  CA  92806
Correspondent Contact Digish Mehta
Regulation Number876.5470
Classification Product Code
EZN  
Subsequent Product Code
LJE  
Date Received03/17/2022
Decision Date 05/05/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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