# K942677: Geenen/Zebra Guidelines

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jul 21, 1994 after 44 days
- Product code: FDE (Laparoscopy Kit)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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; 2 cite 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
- K011759: Radius Next Generation Guidewire (2001), 4 descendants of its own
- K023603: Endo-Glide Guidewire (2003), 2 descendants of its own
- K051068: Zutron Colonoscope Stiffening Device (2005), 1 descendant of its own
- K251204: FUJIFILM Stiffening Wire Device (SW-2000) (2025), 0 descendants of its own
- K050304: FX Wire Advanced Measurement Guidewire (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K942677
Methodology: https://510kreport.com/methodology