# K200680: Synvitro Hyadase

- Pathway: 510(k) (Special)
- Applicant: Origio A/S, A Coopersurgical Company
- Decided: Jul 17, 2020 after 123 days
- Product code: MQL (Media, Reproductive)
- Device class: 2
- Regulation: 21 CFR 884.6180
- 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 K991334 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031228: Synvitro Hyadase, Medicult A/S (2003) Summary page 4.

## Most influential descendants
- K222606: V-Hyadase (2023), 0 descendants of its own

## Indications for use
SynVitro® Hyadase is for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.

Source page: https://510kreport.com/device/K200680
Methodology: https://510kreport.com/methodology