# K830945: Sur-Fit Flexible

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, A Division of E.R. Squibb & Sons
- Decided: Apr 12, 1983 after 19 days
- Product code: EXB (Collector, Ostomy)
- Device class: 1
- Regulation: 21 CFR 876.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K040110: Easy Loop, Model Ezl-01 (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K830945
Methodology: https://510kreport.com/methodology