# K972148: B.U.S. Endotron

- Pathway: 510(k) (Traditional)
- Applicant: Medicamat S.A.
- Decided: Dec 10, 1997 after 184 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Endotron® units are for use by skilled physicians who use them in accordance with procedures and practices taught in special medical training. No specific use instructions are herein provided other than those included in th er’s Manual (Document A-2).

Source page: https://510kreport.com/device/K972148
Methodology: https://510kreport.com/methodology