# K945576: Meadox Surgimed Noprofile (TM) Olbert Catheter System (R)

- Pathway: 510(k) (Traditional)
- Applicant: Meadox Medicals, Div. Boston Scientific Corp.
- Decided: Jan 24, 1995 after 71 days
- Product code: EZN (Dilator, Catheter, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K973113: Modified Olbert Balloon Catheter System, Noprofile Olbert Balloon Catheter System (1997), 1 descendant of its own
- K010714: Expander, Models 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830 (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K945576
Methodology: https://510kreport.com/methodology