Pathway Ureteral Access Sheath, Pathway Expandable Ureteral Access Sheath
FDA 510(k) K043254 · Onset Medical Corporation
510(k) numberK043254
Submission
- Device name
- Pathway Ureteral Access Sheath, Pathway Expandable Ureteral Access Sheath
- Applicant
- Onset Medical Corporation
Mission Viejo, CA, US - Received
- November 24, 2004
- Decision date
- February 10, 2005
- 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 |
| K220781 | ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal…EZN · Traditional | Allwin Medical Devices, Inc. | 05/05/2023SE |
| 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 |
More from Olympus Surgical Technologies America
| 510(k) | Device | Decision |
|---|---|---|
| K152498 | SoloPath Re-Collapsible Access SystemDYB · Traditional | 01/05/2016SE |
| K121404 | Solopath Re-Collapsible Access SystemDYB · Traditional | 05/03/2013SE |
| K112629 | Onset Access Catheter SystemDQY · Traditional | 10/11/2011SE |
| K100819 | The Solopath Balloon Expandable Transfemoral IntroducerDYB · Special | 08/02/2010SE |
| K092014 | Solopath Balloon Expandable Transfemoral IntroducerDYB · Traditional | 10/08/2009SE |
| K062852 | Balloon Expandable Transseptal Indroducer, Models BETI-1840 and BETI-1870DYB · Traditional | 02/23/2007SE |
| K061009 | Pathway Balloon Expandable Ureteral Access Sheath, Model BeusEZN · Special | 05/02/2006SE |
Questions and answers
When was Pathway Ureteral Access Sheath, Pathway Expandable Ureteral Access Sheath cleared by the FDA?
Pathway Ureteral Access Sheath, Pathway Expandable Ureteral Access Sheath (K043254) received a 510(k) decision of Substantially Equivalent on February 10, 2005, 78 days after the submission was received.
What is the product code of K043254?
The FDA product code is EZN – Dilator, Catheter, Ureteral, a Class II (moderate risk) device regulated under 21 CFR 876.5470.