# K990341: Electro Mechanical Lithotriptor

- Pathway: 510(k) (Traditional)
- Applicant: Northgate Technologies, Inc.
- Decided: Jul 14, 1999 after 161 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
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) Medispecs’ Lithospec™: named in the summary without a submission number
- (no number) EMS Swiss Lithoclast: named in the summary without a submission number

## Indications for use
The Nortech® Electro-Mechanical Lithotriptor (EML) was designed to be used with Nortechs’® Intracorporeal Electro-Mechanical Lithotriptor Probes for the fragmentation of urinary calculi.

Source page: https://510kreport.com/device/K990341
Methodology: https://510kreport.com/methodology