# K983374: Agatha-a-H2010

- Pathway: 510(k) (Traditional)
- Applicant: Midian Intl.
- Decided: Dec 23, 1998 after 89 days
- Product code: EFS (Unit, Oral Irrigation)
- Device class: 1
- Regulation: 21 CFR 872.6510
- 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
/f/o Repove CLc/A.ere,h.f F’/flfiu‘i and Fogp ydaks ri's O‘fraw‘ Yhe Tetd and 94&/m£4605&= A0 Weduce oottt c{ec,aj i palients twho Grz /“’/fig,y,hf“‘ fio,ozr&/?m», ww Mfiv be assoctafec

Source page: https://510kreport.com/device/K983374
Methodology: https://510kreport.com/methodology