510(k) K233411 ยท EZL Catheter, Retention Type, Balloon
Folysil Silicone Catheter
| Applicant | Coloplast Corp., Plymouth MN, US |
| Decision | Substantially Equivalent, Apr 15, 2024 |
| Received | Oct 6, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233411
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2025 | Coloplast Manufacturing US, LLC Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA632 Open, Classified |
EZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.