# K980492: Aeh-3 Electrohydraulic Lithotripter and Probes (E-1F, E-3F, E-5F, and E-9F)

- Pathway: 510(k) (Traditional)
- Applicant: Circon Acmi
- Decided: Nov 17, 1998 after 281 days
- Product code: FFK (Lithotriptor, Electro-Hydraulic)
- Device class: 2
- Regulation: 21 CFR 876.4480
- Recalls of this device: 4 (0 Class I)
- 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 no predicate by number.

## Recalls of this device
- Apr 30, 2004 · Not classified · Z-0928-04: Product sterility may be compromised due to the lack of package seal integrity
- Apr 30, 2004 · Not classified · Z-0925-04: Product sterility may be compromised due to the lack of package seal integrity
- Apr 30, 2004 · Not classified · Z-0926-04: Product sterility may be compromised due to the lack of package seal integrity
- Apr 30, 2004 · Not classified · Z-0927-04: Product sterility may be compromised due to the lack of package seal integrity

## Indications for use
CIRCON ACMTI’s AEH-3 Electrohydraulic Lithotripter and Probes are intended to be used to fragment stones (calculi) in the urinary and biliary tracts, including the kidney, ureter, bladder, urethra, and common bile duct.

Source page: https://510kreport.com/device/K980492
Methodology: https://510kreport.com/methodology