# K040520: Slip Urology Introducer Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Percutaneous Systems, Inc.
- Decided: May 20, 2004 after 83 days
- Product code: KNY (Accessories, Catheter, G-U)
- 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
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) Memcath's Urology Introducer Sheath: named in the summary without a submission number

## Indications for use
The SLIP Urology Introduction Sheath is intended to facilitate the introduction of catheters and instruments into the urethra. The SLIP Urology Introducer Sheath is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.

Source page: https://510kreport.com/device/K040520
Methodology: https://510kreport.com/methodology