# K974224: Endolymphatic Sac to Mastoid T-Shunt

- Pathway: 510(k) (Traditional)
- Applicant: Exmoor Plastics, Ltd.
- Decided: Jan 27, 1998 after 78 days
- Product code: ESZ (Tube, Shunt, Endolymphatic)
- Device class: 2
- Regulation: 21 CFR 874.3820
- 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) Richards Endolymphatic Shunt Tube (Austin Modification): named in the summary without a submission number
- (no number) Richards Silicone Elastomer Endolymphatic Shunt Tube (House type): named in the summary without a submission number

## Indications for use
Endolymphatic Sac fluid increases during Meniere's disease attacks. This simple 'T" type endolymphatic sac shunt is designed to act as a continuous drain, allowing endolymphatic sac fluid to be shunted into the Mastoid. The shunt is placed in the sac along with decompression of the sac and the adjacent dura.

Source page: https://510kreport.com/device/K974224
Methodology: https://510kreport.com/methodology