# K970704: Personal Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Rochester Medical Corp.
- Decided: Mar 13, 1997 after 15 days
- Product code: GBM (Catheter, Urethral)
- 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: 1 generation back to K943851 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943851: All Silicone Intermittent Catheter, Rochester Medical Corp. (1995) Summary page 1.
- (no number) Bard Urology Inc. Urethral Catheters: named in the summary without a submission number

## Indications for use
The device is intended for use for urethral or intermittent catheterization. Device sizes are supplied for pediatric and adult male and female applications

Source page: https://510kreport.com/device/K970704
Methodology: https://510kreport.com/methodology