# K070873: Amsure Bladder Irrigation Set

- Pathway: 510(k) (Traditional)
- Applicant: Amsino Intl., Inc.
- Decided: Dec 19, 2007 after 265 days
- Product code: LJH (System, Irrigation, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K934382 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970946: Medline Y-Type Tur/Bladder Irrigation Set, Medline Industries, Inc. (1997) Summary page 1.

## Indications for use
The AMSure® Bladder Irrigation Set is intended for the infusion of fluids to evacuate the bladder. It is also indicated for use in such procedures as cystoscopies and transurethral-resections as a means of continuous bladder irrigation.

Source page: https://510kreport.com/device/K070873
Methodology: https://510kreport.com/methodology