# K141663: Eeva Dish (with 12 Microwells)

- Pathway: 510(k) (Special)
- Applicant: Auxogyn, Inc.
- Decided: Jul 22, 2014 after 29 days
- Product code: MQK (Labware, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K993881 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103028: Eevatm Petri Dish, Auxogyn, Inc. (2011) Summary page 1.

## Indications for use
The EevaTM Dish is intended to be used to hold human oocytes and embryos during handling and culture.

Source page: https://510kreport.com/device/K141663
Methodology: https://510kreport.com/methodology