# K172978: SurgeoBite

- Pathway: 510(k) (Traditional)
- Applicant: Surgovations, LLC
- Decided: Dec 22, 2017 after 86 days
- Product code: JXL (Block, Bite)
- Device class: 2
- Regulation: 21 CFR 882.5070
- 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 K992269 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992269: Ventil-a Oral Protector, Somatics, Inc. (1999) Summary page 4.

## Most influential descendants
- K221469: PATI (Protector Against Tongue Injury) (2023), 0 descendants of its own

## Indications for use
The SurgeoBite® device is single-use (disposable) oral protector for use during seizures induced by electroconvulsive therapy, spontaneous seizures, neuromonitoring stimulation, and any circumstances requiring protection of the teeth, lips, tongue, and buccal mucosa.

Source page: https://510kreport.com/device/K172978
Methodology: https://510kreport.com/methodology