# K172247: Magic3 Go Intermittent Urinary Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Sep 20, 2017 after 56 days
- Product code: EZD (Catheter, Straight)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 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)
- K150345: Magic3 Go Intermittent Urinary Catheter, C.R. Bard, Inc. (2015) Summary page 4.
- K000723: Hydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and Non-Hydrophilic), Rochester Medical Corp. (2000) Summary page 4.

## Recalls of this device
- Apr 20, 2023 · Class II · Z-1700-2023: Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product s
- Apr 20, 2023 · Class II · Z-1699-2023: Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product s

## Indications for use
The Magic3 Go® Intermittent Urinary Catheter is intended for urological use only. It is intended for use by adult and pediatric patients of all ages for bladder management including urine drainage, collection, and measurement. The device is passed to the urinary bladder via the urethra.

Source page: https://510kreport.com/device/K172247
Methodology: https://510kreport.com/methodology