# K011911: Suction Pump for Intracorporeal Ultrasound Lithotripter and Accessories, Model 2207.XXX

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Sep 17, 2001 after 90 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
Longest line of descent: 1 generation back to K011065 (2001). 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)
- K011065: Intracorporeal Ultrasound Lithotripter, Model 2271.004, Ultrasound Transducer, Model 2271.501, Ultrasound Probes (Sono), Richard Wolf Medical Instruments Corp. (2001)
- (no number) Suction pump 2017.00: named in the summary without a submission number

## Recalls of this device
- Feb 2, 2004 · Not classified · Z-0537-04: If the drain tube is assembled incorrectly, the suction pump will not operate as intended.

## Indications for use
Suction pump 2207 with its accessories is used to aspirate liquids in ultrasound lithotripsy. It has been designed for combined use with the ultrasound generator 2271. In conjunction with ultrasound generator 2271 the suction pump is exclusively used for aspiration of disintegrated kidney stones, bladder stones and ureter stones and the liquid involved. Contraindications: Contraindications directly related to the product are presently unknown. On the basis of the patient's general condition the doctor in charge must decide whether the planned use is possible or not. For further information see the latest medical literature. Combinations: The R.Wolf “Suction Pump 2207” is specially designed for use with an ultrasound lithotriptor. It is specially designed for combined use with the WOLF US-LITHO 2271. If the suction pump is to be used in conjunction with other ultrasound lithotriptors (other marks, brands), the user must check whether the device combination can reach and maintain the required functions on a continuous basis.

Source page: https://510kreport.com/device/K011911
Methodology: https://510kreport.com/methodology