# K943635: Ultra-Line Rongeur

- Pathway: 510(k) (Traditional)
- Applicant: V. Mueller Neuro/Spine
- Decided: Dec 7, 1994 after 133 days
- Product code: HAE (Rongeur, Manual)
- Device class: 2
- Regulation: 21 CFR 882.4840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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
- K081651: Instrumed Rongeur (2008), 3 descendants of its own
- K150468: Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs (2016), 1 descendant of its own
- K210741: KLS Martin Neuro Rongeurs (2022), 0 descendants of its own
- K131851: Osteomed Neuro Rongeur (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K943635
Methodology: https://510kreport.com/methodology