GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER
FDA 510(k) clearance K132181 · decided 2013-10-21
Clearance details
- K-number
- K132181
- Device name
- GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER
- Applicant
- Olympus Surgical Technologies America
- Decision
- Substantially Equivalent
- Date received
- 2013-07-15
- Decision date
- 2013-10-21
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- EZN
- Device class
- 2
- Regulation number
- 876.5470
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Southborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Optilume® High Pressure Urological Balloon Dilation Catheter (K250910) | Urotronic, Inc. | 2025-05-22 |
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| In-Ka Ureteral Balloon Dilatation Catheter (K201007) | Coloplast Corp. | 2020-06-11 |
| EQUINOX Balloon Dilatation Catheter (K190612) | Dornier Medtech America, Inc. | 2019-12-06 |
| Ureteral Dilator Sets, Ureteral Dilators (K173654) | Cook Incorporated | 2018-07-17 |
| Safety Wire Guide Introducer (K180756) | Cook Incorporated | 2018-05-24 |
| Cook 810 Set, Desilets-Hoffman Introducer Set (K180028) | Cook Incorporated | 2018-05-02 |
| Balloon Catheter and Balloon Ureteral Dilator Set (K172588) | Cook Incorporated | 2018-04-19 |
| Ureteral Dilators and Percutaneous Nephrostomy Dilators (K170531) | Coloplast Corp. | 2017-08-17 |
| UROMAX ULTRA BALLOON DILATATION CATHETER (K130804) | Boston Scientific Corporation | 2013-05-22 |
| PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS (K061009) | Onset Medical Corporation | 2006-05-02 |
| U-BALLOON DILATION CATHETER (K050875) | C.R. Bard, Inc. | 2005-05-26 |
Recalls involving this device
No recalls on record reference this clearance.