# K860358: Fleischman-Swartz Endo-Ocular Probe (Sterile)

- Pathway: 510(k) (Traditional)
- Applicant: Hgm, Inc.
- Decided: Mar 21, 1986 after 50 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K032357: Novus TTX Laser and Delivery Devices with Accessories (2003), 5 descendants of its own
- K052526: Novus 3000 Laser System and Delivery Devices (2005), 4 descendants of its own
- K062336: Optimedica Laser Indirect Ophthalmoscope (2006), 1 descendant of its own
- K061025: Accutech Endolite Probe (2006), 1 descendant of its own
- K123056: Pascal Laser Indirect Ophthalmoscope (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K860358
Methodology: https://510kreport.com/methodology