ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- GLIDER Amplatz Sheath EUDAMEDARMADA Dilators & Sets EUDAMEDARMADA Dilators & Sets, GLIDER Amplatz Sheath EUDAMED
- Device Name
- DILATORS & SETS EUDAMED
- Model / Reference
- AM24 EUDAMEDFD6 EUDAMEDUD16 EUDAMEDUD12 EUDAMEDRD-AM26/30 EUDAMEDAM22 EUDAMEDUD14 EUDAMEDAM26 EUDAMEDUDS6/16-60 EUDAMEDAM30 EUDAMEDRD-AM18/30 EUDAMEDFD10 EUDAMEDRD-AM16/30 EUDAMEDARDS8/30 EUDAMEDFD8 EUDAMEDAM28 EUDAMEDARDS8/30-FS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00812261012926 EUDAMED00812261012735 EUDAMED00812261012681 EUDAMED00812261012667 EUDAMED00812261018621 EUDAMED00819374021227 EUDAMED00812261012674 EUDAMED00812261012933 EUDAMED00812261012629 EUDAMED00812261012957 EUDAMED00819374020060 EUDAMED00812261012773 EUDAMED00819374021203 EUDAMED00812261012834 EUDAMED00812261012759 EUDAMED00812261012940 EUDAMED00812261012841 EUDAMED
- Basic UDI-DI
- 081226101DST010RV EUDAMED
- 510(k) Number
- K220781 FDA 510(k)
- FDA Product Code
- EZN FDA 510(k)
- EMDN Code
- U03010101 AMPLATZ CANNULAS FOR URINARY DILATION EUDAMEDU03010199 PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER EUDAMEDU03010202 URETERAL DILATORS EUDAMEDU03010101,U03010199 EUDAMEDU03010101,U03010199,U0380 EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5470 FDA 510(k)
- Regulation Number
- 876.5470 FDA 510(k)
- Market of Registration
- Romania EUDAMEDCzechia EUDAMEDGreece EUDAMEDTürkiye EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The ARMADA series comprises ureteral and renal dilators, sheaths, and catheters designed for controlled dilation of the ureter and renal tract. These devices include step-by-step and one-step ureteral dilators, Amplatz renal dilators, fascial dilators, and introducer sheaths, all classified under the nomenclature for dilators and catheters. They are intended for use in urological procedures to facilitate access and stone manipulation within the urinary system.
The ARMADA instruments are supplied as sterile, single-use surgical tools for clinical or surgical settings, with sizes and configurations tailored for specific anatomical applications. They comply with FDA 510(k) clearance and EU MDR requirements, falling under device class II regulatory classification (876.5470). Storage and handling follow standard sterile surgical instrument protocols, ensuring compatibility with urological procedures while adhering to regulatory standards.
Frequently asked questions
What types of procedures are the ARMADA dilators and sheaths designed to assist with in the urinary system?
The ARMADA series is specifically designed for urological procedures to facilitate controlled dilation of the ureter and renal tract. This includes creating access for stone manipulation, such as lithotripsy, or other interventions within the urinary system, ensuring safe passage for instruments and materials.
Are the ARMADA instruments reusable or intended for single-use only, and how should they be stored?
The ARMADA instruments are supplied as sterile, single-use surgical tools. They must be stored following standard sterile surgical instrument protocols to maintain compatibility with urological procedures and regulatory compliance.
What regulatory pathways have the ARMADA devices undergone, and what does this mean for their use?
The ARMADA devices have undergone FDA 510(k) clearance and comply with EU MDR requirements, classified under device class II (876.5470). This means they meet stringent regulatory standards for safety and performance, ensuring they are suitable for clinical and surgical settings as intended.
What anatomical applications are the ARMADA dilators and sheaths tailored for, and how are they configured?
The ARMADA series includes sizes and configurations tailored for specific anatomical applications in the ureter and renal tract. This includes step-by-step and one-step ureteral dilators, Amplatz renal dilators, fascial dilators, and introducer sheaths, ensuring versatility for different procedural needs.
How do I know which specific ARMADA product is best suited for my procedure, given the variety of options?
The ARMADA series offers multiple specialized tools, such as the Nottingham One Step Dilator for ureteral dilation, Amplatz Renal Dilators for renal access, and introducer sheaths for guiding catheters. The choice depends on the anatomical target and procedural requirements—consult product documentation or a medical specialist to select the appropriate size and type for your case.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA ..., PDF K220781 - ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step ..., Allwin Medical Devices, Inc. FDA 510 (k) Products 2023
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K220781 | Class II | Active |
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Manufacturer
- Manufacturer
- Allwin Medical Devices, Inc.
Sources (18)
- FDA 510(k) K220781 24 fields · synced Sep 18, 2026
- EUDAMED 1c478fb4-67c9-40ab-be0b-86c8bbc73fd5 61 fields · synced Jul 9, 2026
- EUDAMED a17b7d14-fc34-45a3-b526-aa7bd1b83ef6 61 fields · synced Jul 10, 2026
- EUDAMED 7d3e6859-4777-4608-ad4b-ab3d4faa78e2 61 fields · synced Jul 11, 2026
- EUDAMED 8a469459-236d-487d-8b4f-1395723b2910 61 fields · synced Jul 14, 2026
- EUDAMED 6d815cca-c09a-467c-be1b-074643f1a91f 61 fields · synced Jul 15, 2026
- EUDAMED 289b26f9-2d79-4ceb-9a55-60e9f29c4a4e 61 fields · synced Jul 16, 2026
- EUDAMED bb2af165-7321-4698-91a2-588d3ca14e9e 61 fields · synced Jul 18, 2026
- EUDAMED 56a41417-508f-454e-a1fa-0b976e21ecbb 61 fields · synced Jul 20, 2026
- EUDAMED 3463ee71-3dea-4b94-ba8a-f993f2420ebe 61 fields · synced Jul 20, 2026
- EUDAMED 16bce433-4036-43e9-ad49-afd5ba179969 61 fields · synced Jul 21, 2026
- EUDAMED 73672917-35d5-4867-a9da-4e75cbf090e3 61 fields · synced Jul 23, 2026
- EUDAMED 332b8f4f-91a5-49ad-b5f9-c13e429053a6 61 fields · synced Jul 25, 2026
- EUDAMED 365507a0-6c4f-4d28-b7ca-95c4e5fb8e25 61 fields · synced Aug 2, 2026
- EUDAMED 3cb036a4-1f5d-41fd-895e-4aa54365c9d9 61 fields · synced Aug 4, 2026
- EUDAMED caf9d726-d2a2-4d79-98d2-a6cf0dc0c5d9 61 fields · synced Sep 17, 2026
- EUDAMED 877ab93f-707a-4b0a-adb3-3e136ddb0d85 61 fields · synced Sep 17, 2026
- EUDAMED b2a4fbf5-ebdb-470e-a2f6-072b3e6bf97a 61 fields · synced Sep 17, 2026