# K991334: Medi-Cult Hyaluronidase;

- Pathway: 510(k) (Traditional)
- Applicant: Medicult A/S
- Decided: Jun 20, 2000 after 428 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
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K031228: Synvitro Hyadase (2003), 5 descendants of its own
- K060699: Synvitro Cumulase (Hyaluronidase Medium) (2006), 2 descendants of its own
- K042495: Cumulase (2005), 2 descendants of its own
- K200680: Synvitro Hyadase (2020), 1 descendant of its own
- K081639: Icsi Cumulase (2008), 1 descendant of its own

## Indications for use
For use in assisted reproduction techniques, (ART), such as IVF, GIFT or similar in vitro procedure to aid in facilitating pregnancy. Medi-Cult Hyaluronidase is for the removal of cumulus and corona radiatacells which must be removed in order to facilitate access to the oocyte and minimize contamination of the injected needle before ICSI.

Source page: https://510kreport.com/device/K991334
Methodology: https://510kreport.com/methodology