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— 510(k) K220781
Substantially EquivalentAllwin Medical Devices, Inc.
FDA 510(k) clearance K220781 for 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, Substantially Equivalent on 2023-05-05. Applicant: Allwin Medical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Allwin Medical Devices, Inc.
- Product code
- Product code EZN
- Device class
- Class 2
- Regulation
- 21 CFR 876.5470
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Anaheim, CA, US
Recent devices under product code EZN
view allMore clearances from Allwin Medical Devices, Inc.
view all- K261234 — The D-Tip Denudation Pipette
- K220730 — allFlex Ureteral Catheters, Krait Ureteral Catheters
- K203626 — SureStrip Vitrification Straw, SureLock Vitrification Straw
- K200248 — Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
- K190659 — 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/Closed Tip
Adverse events under product code EZN
product code EZN- Death
- 3
- Injury
- 127
- Total
- 130
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.