# K220781: 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

- Pathway: 510(k) (Traditional)
- Applicant: Allwin Medical Devices, Inc.
- Decided: May 5, 2023 after 414 days
- Product code: EZN (Dilator, Catheter, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
ARMADA Ureteral Dilator Set: Used for step by step dilatation of the intramural and ureter and / or for stone manipulation. ARMADA Nottingham One Step Dilator: Used for one step dilatation of the intramural portion and ureter. ARMADA Amplatz Renal Dilator Set: Used for progressive dilatation for tract prior to percutaneous kidney stone removal. ARMADA Renal Dilator: Used for dilatation of Renal Tract. Glider Amplatz Sheath: Used to maintain previously established nephrostomy tract. Fascial Dilator: Fascial Dilators are used for dilatation of percutaneous track over the guidewire. Introducer Sheath: Used for introducing safety wire during nephrostomy. Introducer Catheter: Used for guiding renal dilators for establishing nephrostomy tract.

Source page: https://510kreport.com/device/K220781
Methodology: https://510kreport.com/methodology