# K233658: Biowy Tym Tube (TT)

- Pathway: 510(k) (Traditional)
- Applicant: Biowy Corporation
- Decided: Feb 16, 2024 after 93 days
- Product code: ETD (Tube, Tympanostomy)
- Device class: 2
- Regulation: 21 CFR 874.3880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K830228 (1983). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830228: Otological Ventilation Tubes-Various, Micromedics, Inc. (1983) Summary page 4.

## Indications for use
The Biowy Tym Tube products are indicated for where chronic Eustachian tube dysfunction does not respond to conventional therapy.

Source page: https://510kreport.com/device/K233658
Methodology: https://510kreport.com/methodology