# K981233: Ksea Calcusplit

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Jun 15, 1998 after 73 days
- Product code: FFK (Lithotriptor, Electro-Hydraulic)
- 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
Longest line of descent: 2 generations back to K863642 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951531: Swiss Lithoclast Lithotripter, Electro Medical Systems SA (1995) Summary page 1.
- K963285: Ems Swiss Lithoclast Lithotripter, Electro Medical Systems SA (1997) Summary page 1.

## Indications for use
These instruments are intended for use by qualified surgeons and provide for the intracorporeal fragmentation of lower ureter and renal calculi.

Source page: https://510kreport.com/device/K981233
Methodology: https://510kreport.com/methodology