# K923922: Surgical Spears

- Pathway: 510(k) (Traditional)
- Applicant: Ultracell Medical Technologies, Inc.
- Decided: Mar 19, 1993 after 226 days
- Product code: HOZ (Sponge, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4790
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K972693: Deroyal Industries, Inc. Surgical Eye Spear (1997), 1 descendant of its own
- K130117: Network Eye Spears, Points, Drains, Wicks and Shields (2013), 0 descendants of its own

## Recalls of this device
- Jan 8, 2003 · Not classified · Z-0488-03: Sterility of the device is compromised
- Jan 8, 2003 · Not classified · Z-0489-03: Sterility of the device is compromised
- Jan 8, 2003 · Not classified · Z-0487-03: Sterility of the device is compromised

Source page: https://510kreport.com/device/K923922
Methodology: https://510kreport.com/methodology