# K964111: Lithovac Suction/Aspiration Probe

- Pathway: 510(k) (Traditional)
- Applicant: Electro Medical Systems SA
- Decided: Dec 16, 1996 after 62 days
- Product code: KQT (Evacuator, Gastro-Urology)
- Device class: 2
- Regulation: 21 CFR 876.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Uromat Suction Pump/Calcuson Ultrasonic Lithotrite System: named in the summary without a submission number
- (no number) Olympus Ureteromat Pump/LUS Lithotripsy device: named in the summary without a submission number
- (no number) Corson Disposable Suction Irrigation Probe: named in the summary without a submission number
- (no number) Nezhat-Dorsey Hydro-Dissection Reusable Suction Irrigation Probe: named in the summary without a submission number

## Indications for use
The Electro Medical Systems SA LITHOVAC Suction/Aspiration Probe is designed for the suction and aspiration of urinary tract calculi fragments through rigid or semi-rigid endoscopes. It can be used alone, or it can be used during and after fragmentation of urinary tract calculi with the EMS Swiss LITHOCLAST intracorporeal lithotripter. It is specifically designed so that an EMS LITHOCLAST lithotripsy probe can be inserted through the LITHOVAC suction tube so that stone fragments and debris can be aspirated through the LITHOVAC suction tube simultaneously with lithotripsy.

Source page: https://510kreport.com/device/K964111
Methodology: https://510kreport.com/methodology