MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY
FDA 510(k) clearance K904983 · decided 1991-01-30
Clearance details
- K-number
- K904983
- Device name
- MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY
- Applicant
- Meadox Surgimed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-11-02
- Decision date
- 1991-01-30
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- EZN
- Device class
- 2
- Regulation number
- 876.5470
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Oakland, NJ, US
- Third-party review
- No
- Expedited review
- No
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| Ureteral Dilators and Percutaneous Nephrostomy Dilators (K170531) | Coloplast Corp. | 2017-08-17 |
| GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER (K132181) | Olympus Surgical Technologies America | 2013-10-21 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.