GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER
FDA 510(k) clearance K132383 · decided 2014-02-04
Clearance details
- K-number
- K132383
- Device name
- GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER
- Applicant
- Gyrus Acmi, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-07-31
- Decision date
- 2014-02-04
- Days to decision
- 188 days
- Clearance type
- Traditional
- Product code
- LJE
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Southborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: O recall (Z-0572-2026) | Olympus Corporation of the Americas | 2025-11-20 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Spiration® Valve System (P180007/S013) | Gyrus Acmi, Inc. | 2024-08-16 |
| Spiration Valve System Deployment Catheter and Loader (P180007/S012) | Gyrus Acmi, Inc. | 2024-06-27 |
| Spiration Valve System (P180007/S011) | Gyrus Acmi, Inc. | 2023-09-22 |
| SVS Deployment Catheter and Loader (P180007/S009) | Gyrus Acmi, Inc. | 2022-05-12 |
| Spiration Valve System (P180007/S008) | Gyrus Acmi, Inc. | 2021-09-01 |
| Falope Ring Band and Applicator Systems (P870076/S027) | Gyrus Acmi, Inc. | 2021-05-19 |
| Falope-Ring® Band and Applicator Systems (P870076/S026) | Gyrus Acmi, Inc. | 2021-05-11 |
| Spiration® Valve System (SVS) (P180007/S007) | Gyrus Acmi, Inc. | 2020-12-23 |