# K991393: Hyaluronidase, 80 U/ML

- Pathway: 510(k) (Traditional)
- Applicant: Sage Biopharma
- Decided: Feb 2, 2000 after 287 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Hyaluronidase is used prior to intracytoplasmic sperm injections (ICSl) procedures to digest the hyaluronic acid holding the cumulus cells together to permit easy handling of the oocytes.

Source page: https://510kreport.com/device/K991393
Methodology: https://510kreport.com/methodology