Cleared Traditional

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

K220781 · Allwin Medical Devices, Inc. · Gastroenterology & Urology
May 2023
Decision
414d
Days
Class 2
Risk

About This 510(k) Submission

K220781 is an FDA 510(k) clearance for the 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, a Dilator, Catheter, Ureteral (Class II — Special Controls, product code EZN), submitted by Allwin Medical Devices, Inc. (Anaheim, US). The FDA issued a Cleared decision on May 5, 2023, 414 days after receiving the submission on March 17, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5470.

Submission Details

510(k) Number K220781 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2022
Decision Date May 05, 2023
Days to Decision 414 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code EZN — Dilator, Catheter, Ureteral
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5470

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