# K052298: Cystoglide Introducer Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Percutaneous Systems, Incorporated
- Decided: Dec 12, 2006 after 476 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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's UPDATED SLIP Urology Introducer Sheath: named in the summary without a submission number
- (no number) Astra Tech's LoFric catheter: named in the summary without a submission number
- (no number) Rusch's MMG/O'Neil catheter: named in the summary without a submission number

## Most influential descendants
- K131803: Guardian Urethral Sheath (2013), 0 descendants of its own

## Indications for use
The CYSTOGLIDE INTRODUCER SHEATH Urology is intended to facilitate the introduction of catheters and instruments into the urethra. The CYSTOGLIDE 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/K052298
Methodology: https://510kreport.com/methodology