UROPASS URETERAL ACCESS SHEATH, MODEL 61224
FDA 510(k) clearance K051593 · decided 2005-09-02
Clearance details
- K-number
- K051593
- Device name
- UROPASS URETERAL ACCESS SHEATH, MODEL 61224
- Applicant
- Acmi Corporation
- Decision
- Substantially Equivalent
- Date received
- 2005-06-16
- Decision date
- 2005-09-02
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- KNY
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Southborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Ca recall (Z-0364-2025) | Olympus Corporation of the Americas | 2024-11-12 |
| UroPass Ureteral Access Sheaths, 5 pieces/box recall (Z-2401-2023) | Olympus Corporation of the Americas | 2023-08-14 |