# K060699: Synvitro Cumulase (Hyaluronidase Medium)

- Pathway: 510(k) (Traditional)
- Applicant: Medicult A/S
- Decided: May 10, 2006 after 55 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.
2 later devices descend from it; 1 cites it directly.
0 of 5 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 1.

## Most influential descendants
- K081639: Icsi Cumulase (2008), 1 descendant of its own
- K182002: Cumulus Remover (2018), 0 descendants of its own

## Indications for use
SynVitro®CumulaseTM is indicated for the removal of the cell complex (cumulus and corona radiate) surrounding the oocyte in preparation for the ICSI procedure.

Source page: https://510kreport.com/device/K060699
Methodology: https://510kreport.com/methodology