Gyrus Acmi Uro-Ezdilate Ureteral Balloon Dilation Catheter
FDA 510(k) K132181 · Olympus Surgical Technologies America
510(k) numberK132181
Submission
- Device name
- Gyrus Acmi Uro-Ezdilate Ureteral Balloon Dilation Catheter
- Applicant
- Olympus Surgical Technologies America
Southborough, MA, US - Received
- July 15, 2013
- Decision date
- October 21, 2013
- 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 |
| K170531 | Ureteral Dilators and Percutaneous Nephrostomy DilatorsEZN · Traditional | Coloplast Corp. | 08/17/2017SE |
| K130804 | Uromax Ultra Balloon Dilatation CatheterEZN · Traditional | Boston Scientific Corporation | 05/22/2013SE |
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| K163469 | ViziShot 2 FLEXKTI · Traditional | 04/06/2017SE |
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Questions and answers
When was Gyrus Acmi Uro-Ezdilate Ureteral Balloon Dilation Catheter cleared by the FDA?
Gyrus Acmi Uro-Ezdilate Ureteral Balloon Dilation Catheter (K132181) received a 510(k) decision of Substantially Equivalent on October 21, 2013, 98 days after the submission was received.
What is the product code of K132181?
The FDA product code is EZN – Dilator, Catheter, Ureteral, a Class II (moderate risk) device regulated under 21 CFR 876.5470.