# K982599: The Fremstad Ring

- Pathway: 510(k) (Traditional)
- Applicant: Ophthalmic Solutions, LLC
- Decided: Feb 16, 1999 after 204 days
- Product code: HOZ (Sponge, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4790
- 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 its predicate without a number.
- (no number) Visi-Spear Sponge by Visitec: named in the summary without a submission number
- (no number) Eye Cellulose Surgical Sponge distributed by Akorn: named in the summary without a submission number

## Indications for use
Ophthalmic sponge, used to absorb fluids from the surgical area during ophthalmic procedures, not intended to contact the cornea.

Source page: https://510kreport.com/device/K982599
Methodology: https://510kreport.com/methodology