# K182709: One-Step Suprapubic Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Dec 26, 2018 after 90 days
- Product code: KOB (Catheter, Suprapubic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K884061 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884061: Add-a-Cath, Femcare, Ltd. (1988) Summary page 4.

## Indications for use
The One-Step Suprapubic Introducer is used for introducing a drainage catheter suprapubically into the bladder.

Source page: https://510kreport.com/device/K182709
Methodology: https://510kreport.com/methodology