# K182403: Peel-Away Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: May 29, 2019 after 267 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K961904 (1996). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172217: Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath, Cook Incorporated (2017) Summary page 4.
- K123170: Vari-Pass Variable Length Access Sheath, Olympus Surgical Technologies America (2013) Summary page 4.

## Indications for use
The Peel-Away Introducer is intended to be used to establish a conduit during endoscopic urological procedures (e.g. nephrostomy, cystoscopy, ureteroscopy, etc.) facilitating the passage of endoscopes and other instruments into the urinary tract.

Source page: https://510kreport.com/device/K182403
Methodology: https://510kreport.com/methodology