# K042531: Updated Slip Urology Introducer Sheath

- Pathway: 510(k) (Special)
- Applicant: Percutaneous Systems, Incorporated
- Decided: Feb 1, 2005 after 137 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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) PSI SLIP Urology Introducer Sheath: named in the summary without a submission number

## Most influential descendants
- K061663: Endomedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath for Otolaryngoscopes and Bronchoscopes (2006), 0 descendants of its own
- K061324: Emt Quik-Cover Flexible Endoscope Barrier Sheath, Series 1-7 (2006), 0 descendants of its own

## Indications for use
The UPDATED SLIP Urology Introducer Sheath is intended to facilitate the introduction of catheters and instruments into the urethra. The UPDATED 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/K042531
Methodology: https://510kreport.com/methodology