# K022931: Hyaluronidase Solution

- Pathway: 510(k) (Traditional)
- Applicant: Irvine Scientific Sales Co., Inc.
- Decided: Nov 4, 2002 after 61 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. The FDA summary names no predicate by number.

## Indications for use
Hyaluronidase Solution is intended for use in assisted reproductive technology procedures involving the manipulation of gametes or embryos. Specifically, Hyaluronidase Solution is intended for use in removing cumulus cells surrounding oocytes (denudation) in preparation for ICSI or other ART procedures.

Source page: https://510kreport.com/device/K022931
Methodology: https://510kreport.com/methodology