510(k) K220781
- Device
- 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.
- 510(k) number
- K220781
- Product code
- EZN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-05-05
- Date received
- 2022-03-17
- Regulation
- 876.5470
- Classification name
- Dilator, Catheter, Ureteral
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Digish Mehta
- Address
- 3305 E. Mira Loma Ave., Suite 176 Anaheim CA US 92806 92806
FDA Registration Numbers#
- 3006546082
- 3013557562
- 3012649202
- 1825146
- 1018233
- 9610617
- 3043337628
- 3010202439
- 9710641
- 2020550
- 3002807314
- 9681260
- 3005099803
- 1225687
- 3005987240
- 3011050570
- 3007156625
- 3014342096
- 1647149
- 3012322232
- 9610711
- 1037955
- 1000393132
- 1313046
- 1828132
- 3003814961
- 3004730544
- 1000121056
- 8044098
- 3010273872
- 1820334
- 3006082230
- 3005941719
- 1646831
- 3003790304
- 3010707607
- 3030733800
- 2124215
- 3013497507
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EZN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250910 | Optilume® High Pressure Urological Balloon Dilation Catheter | Urotronic, Inc. | 2025-05-22 |
| K201007 | In-Ka Ureteral Balloon Dilatation Catheter | Coloplast Corp. | 2020-06-11 |
| K190612 | EQUINOX Balloon Dilatation Catheter | Dornier Medtech America, Inc. | 2019-12-06 |
| K173654 | Ureteral Dilator Sets, Ureteral Dilators | Cook Incorporated | 2018-07-17 |
| K180756 | Safety Wire Guide Introducer | Cook Incorporated | 2018-05-24 |
| K180028 | Cook 810 Set, Desilets-Hoffman Introducer Set | Cook Incorporated | 2018-05-02 |
| K172588 | Balloon Catheter and Balloon Ureteral Dilator Set | Cook Incorporated | 2018-04-19 |
| K170531 | Ureteral Dilators and Percutaneous Nephrostomy Dilators | Coloplast Corp. | 2017-08-17 |
| K132181 | GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER | Olympus Surgical Technologies America | 2013-10-21 |
| K130804 | UROMAX ULTRA BALLOON DILATATION CATHETER | Boston Scientific Corporation | 2013-05-22 |
| K061009 | PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS | Onset Medical Corporation | 2006-05-02 |
| K050875 | U-BALLOON DILATION CATHETER | C.R. Bard, Inc. | 2005-05-26 |
| K043254 | PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH | Onset Medical Corporation | 2005-02-10 |
| K040127 | COOK URETERAL BALLOON DILATION CATHETER SET | Cook Urological, Inc. | 2004-04-06 |
| K030662 | PATHWAY ACCESS SHEATH CATHETER | Vertelink Corporation | 2003-09-03 |