# K091240: Alphamed Surgical Spear, Model 70-5000

- Pathway: 510(k) (Traditional)
- Applicant: Alphamed, Inc.
- Decided: Oct 23, 2009 after 179 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
AlphaMed Surgical Spears are intended to absorb fluids from the operative field during ophthalmic surgery

Source page: https://510kreport.com/device/K091240
Methodology: https://510kreport.com/methodology