# K011065: Intracorporeal Ultrasound Lithotripter, Model 2271.004, Ultrasound Transducer, Model 2271.501, Ultrasound Probes (Sono)

- Pathway: 510(k) (Special)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: May 9, 2001 after 30 days
- Product code: FFK (Lithotriptor, Electro-Hydraulic)
- Device class: 2
- Regulation: 21 CFR 876.4480
- Recalls of this device: 1 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K011911: Suction Pump for Intracorporeal Ultrasound Lithotripter and Accessories, Model 2207.XXX (2001), 0 descendants of its own

## Recalls of this device
- Oct 9, 2003 · Not classified · Z-0081-04: The sonotrode tube could become blocked by the stone fragments, causing overheating and damage to the device.

Source page: https://510kreport.com/device/K011065
Methodology: https://510kreport.com/methodology