# K052134: Cystoglide Dilating Introducer Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Percutaneous Systems, Inc.
- Decided: Sep 22, 2005 after 48 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) PSI's UPDATED SLIP Urology Introducer Sheath: named in the summary without a submission number
- (no number) Cook Urological's Urethral Dilator Set: named in the summary without a submission number

## Indications for use
The CYSTOGLIDE DILATING INTRODUCER SHEATH Urology is intended to dilate urethral strictures and to facilitate the introduction of catheters and instruments into the urethra. The CYSTOGLIDE DILATING INTRODUCER SHEATH is indicated for use as a urethral dilator and 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/K052134
Methodology: https://510kreport.com/methodology