510(k) K132383 ยท LJE Catheter, Nephrostomy
GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER
| Applicant | Gyrus Acmi, Inc., Southborough MA, US |
| Decision | Substantially Equivalent, Feb 4, 2014 |
| Received | Jul 31, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132383
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2025 | Olympus Corporation of the Americas Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit
Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter
Model/Catalog Number: BPCN0815K
Product Description: The N Open, Classified |
LJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.