# K141252: Guardian Urethral Sheath

- Pathway: 510(k) (Special)
- Applicant: Solace Therapeutics
- Decided: Jun 9, 2014 after 26 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K162356: Vesair Cystoscopic Sheath (2017), 0 descendants of its own

## Indications for use
The Guardian Urethral Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The Guardian Urethral 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/K141252
Methodology: https://510kreport.com/methodology