# K952513: Lese Stents Sets

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Jun 10, 1996 after 377 days
- Product code: FAD (Stent, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.4620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cook Urological® Ureteral and Urethral Stents: named in the summary without a submission number
- (no number) Cook Urological® EchoSight® Sof-Flex® Stents: named in the summary without a submission number
- (no number) Cook Urological® SlipCoat™ Stents: named in the summary without a submission number

## Indications for use
The LSe Stent Sets are used for temporary internal drainage from the ureteropelvic junction to the bladder.

Source page: https://510kreport.com/device/K952513
Methodology: https://510kreport.com/methodology