# K171024: ShockPulse-SE Lithotripsy System

- Pathway: 510(k) (Traditional)
- Applicant: Cybersonics, Inc.
- Decided: Aug 21, 2017 after 138 days
- Product code: FEO (Lithotriptor, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 876.4480
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K863642 (1986). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142428: Shock Pulse-SE Lithotripsy System CYBERWAND II, Cybersonics, Inc. (2014) Summary page 4.

## Recalls of this device
- Jan 8, 2026 · Class II · Z-1494-2026: Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility
- Nov 14, 2025 · Class II · Z-1479-2026: Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator recepta
- Nov 14, 2025 · Class II · Z-1478-2026: Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator recepta
- Nov 14, 2025 · Class II · Z-1477-2026: Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator recepta
- Oct 8, 2025 · Class II · Z-0452-2026: The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradual
- Jul 7, 2022 · Class II · Z-1514-2022: Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility

## Indications for use
ShockPulse-SE Lithotripsy System is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.

Source page: https://510kreport.com/device/K171024
Methodology: https://510kreport.com/methodology