# K223756: SimPro™ Now, GentleCath™ Hydrophilic

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: May 4, 2023 after 140 days
- Product code: EZD (Catheter, Straight)
- 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
Longest line of descent: 4 generations back to K910022 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062444: HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and Kit, Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. (2007) Summary page 4.

## Indications for use
SimPro™ Now is for Clean Intermittent Catheterization-CIC treatment and is indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder. GentleCath™ Hydrophilic is for Clean Intermittent Catheterization-CIC treatment and is indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.

Source page: https://510kreport.com/device/K223756
Methodology: https://510kreport.com/methodology