Ureteral Dilators and Percutaneous Nephrostomy Dilators
FDA 510(k) K170531 · Coloplast Corp.
510(k) numberK170531
Submission
- Device name
- Ureteral Dilators and Percutaneous Nephrostomy Dilators
- Applicant
- Coloplast Corp.
Plymouth, MN, US - Received
- February 22, 2017
- Decision date
- August 17, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
|---|---|---|
| K252140 | Heylo SystemEXB · Traditional | 10/06/2025SE |
| K251116 | Luja CoudéEZD · Traditional | 06/27/2025SE |
| K250270 | Luja SetEZD · Special | 04/17/2025SE |
| K242049 | SureCath SetEZD · Traditional | 11/26/2024SE |
| K241210 | Luja CoudeEZD · Traditional | 11/21/2024SE |
| K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10…FED · Traditional | 11/12/2024SE |
| K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551)…PAH · Traditional | 10/18/2024SE |
| K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)EZD · Traditional | 07/26/2024SE |
| K233411 | Folysil Silicone CatheterEZL · Traditional | 04/15/2024SE |
| K231953 | Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x…FRO · Traditional | 03/22/2024SE |
Questions and answers
When was Ureteral Dilators and Percutaneous Nephrostomy Dilators cleared by the FDA?
Ureteral Dilators and Percutaneous Nephrostomy Dilators (K170531) received a 510(k) decision of Substantially Equivalent on August 17, 2017, 176 days after the submission was received.
What is the product code of K170531?
The FDA product code is EZN – Dilator, Catheter, Ureteral, a Class II (moderate risk) device regulated under 21 CFR 876.5470.