# K973251: Ksea Calcuson

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Jun 22, 1998 after 297 days
- Product code: FEO (Lithotriptor, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 876.4480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K052135: Cybersonics Cyberwand Dual Probe Lithotripter (2005), 6 descendants of its own
- K102169: Cyberwand Lithotripter (2010), 5 descendants of its own
- K120303: Cyberwand Dual Action Ultrasonic Lithotripsy System (2012), 3 descendants of its own
- K142428: Shock Pulse-SE Lithotripsy System CYBERWAND II (2014), 1 descendant of its own
- K171024: ShockPulse-SE Lithotripsy System (2017), 0 descendants of its own

## Indications for use
These instruments are intended for use by qualified surgeons and provide for the fragmentation of renal, ureteral and bladder calculi.

Source page: https://510kreport.com/device/K973251
Methodology: https://510kreport.com/methodology