Accent DG Balloon Ureteral Dilator Set
FDA 510(k) K905375 · Cook Urological, Inc.
510(k) numberK905375
Submission
- Device name
- Accent DG Balloon Ureteral Dilator Set
- Applicant
- Cook Urological, Inc.
Spencer, IN, US - Received
- November 30, 1990
- Decision date
- April 12, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EZN – Dilator, Catheter, Ureteral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5470
- Specialty
- Gastroenterology, Urology
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| 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 |
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| K080525 | Cook Odyssey Holmium Laser System, Model 30WGEX · Traditional | 04/17/2008SE |
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Questions and answers
When was Accent DG Balloon Ureteral Dilator Set cleared by the FDA?
Accent DG Balloon Ureteral Dilator Set (K905375) received a 510(k) decision of Substantially Equivalent on April 12, 1991, 133 days after the submission was received.
What is the product code of K905375?
The FDA product code is EZN – Dilator, Catheter, Ureteral, a Class II (moderate risk) device regulated under 21 CFR 876.5470.