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
FDA 510(k) K220781 · Allwin Medical Devices, Inc.
510(k) numberK220781
Submission
- 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.
Anaheim, CA, US - Received
- March 17, 2022
- Decision date
- May 5, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- EZN – Dilator, Catheter, Ureteral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5470
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EZN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250910 | Optilume® High Pressure Urological Balloon Dilation CatheterEZN · Traditional | Urotronic, Inc. | 05/22/2025SE |
| K201007 | In-Ka Ureteral Balloon Dilatation CatheterEZN · Traditional | Coloplast Corp. | 06/11/2020SESK |
| K190612 | EQUINOX Balloon Dilatation CatheterEZN · Traditional | Dornier Medtech America, Inc. | 12/06/2019SE |
| K173654 | Ureteral Dilator Sets, Ureteral DilatorsEZN · Traditional | Cook Incorporated | 07/17/2018SE |
| K180756 | Safety Wire Guide IntroducerEZN · Traditional | Cook Incorporated | 05/24/2018SE |
| K180028 | Cook 810 Set, Desilets-Hoffman Introducer SetEZN · Traditional | Cook Incorporated | 05/02/2018SE |
| K172588 | Balloon Catheter and Balloon Ureteral Dilator SetEZN · Traditional | Cook Incorporated | 04/19/2018SESK |
| K170531 | Ureteral Dilators and Percutaneous Nephrostomy DilatorsEZN · Traditional | Coloplast Corp. | 08/17/2017SE |
| K132181 | Gyrus Acmi Uro-Ezdilate Ureteral Balloon Dilation CatheterEZN · Traditional | Olympus Surgical Technologies America | 10/21/2013SE |
| K130804 | Uromax Ultra Balloon Dilatation CatheterEZN · Traditional | Boston Scientific Corporation | 05/22/2013SE |
More from Boston Scientific Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K220730 | allFlex Ureteral Catheters, Krait Ureteral CathetersKOD · Traditional | 10/13/2022SE |
| K203626 | SureStrip Vitrification Straw, SureLock Vitrification StrawMQK · Traditional | 06/04/2021SE |
| K200248 | Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft ObturatorsMQF · Traditional | 07/01/2020SE |
| K190659 | Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via…FAD · Traditional | 12/02/2019SESK |
| K190590 | Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen…MQE · Traditional | 11/25/2019SE |
| K190522 | Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra…MQF · Traditional | 11/14/2019SE |
Questions and answers
When was 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 cleared by the FDA?
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) received a 510(k) decision of Substantially Equivalent on May 5, 2023, 414 days after the submission was received.
What is the product code of K220781?
The FDA product code is EZN – Dilator, Catheter, Ureteral, a Class II (moderate risk) device regulated under 21 CFR 876.5470.