# K120160: Rocamed Rocaus Platinum

- Pathway: 510(k) (Traditional)
- Applicant: Promepla Sam
- Decided: May 14, 2012 after 116 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
Longest line of descent: 3 generations back to K961904 (1996). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051593: Uropass Ureteral Access Sheath, Model 61224, Acmi Corporation (2005) Summary page 1.
- K030956: Navigator Ureteral Access Sheath Set, Boston Scientific Corp (2003) Summary page 1.

## Most influential descendants
- K140441: BI-Flex Ureteral Access Sheath (2014), 1 descendant of its own
- K182144: Bi-Flex Evo (2018), 0 descendants of its own

## Indications for use
The ROCAMED RocaUS Platinum is intended to be a condluit for passage of endloscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.

Source page: https://510kreport.com/device/K120160
Methodology: https://510kreport.com/methodology