510(k) K051593 ยท KNY Accessories, Catheter, G-U
UROPASS URETERAL ACCESS SHEATH, MODEL 61224
| Applicant | Acmi Corporation, Southborough MA, US |
| Decision | Substantially Equivalent, Sep 2, 2005 |
| Received | Jun 16, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051593
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 12, 2024 | Olympus Corporation of the Americas Brand Name: UroPass Ureteral Access Sheaths
Product Name: Ureteral Access Sheaths
Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246B Open, Classified |
KNY | None listed |
| Aug 14, 2023 | Olympus Corporation of the Americas UroPass Ureteral Access Sheaths, 5 pieces/box Open, Classified |
KNY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.