# K942987: Nucleotome L Kit

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Dynamics, Inc.
- Decided: Oct 30, 1995 after 497 days
- Product code: GET (Motor, Surgical Instrument, Pneumatic Powered)
- Device class: 1
- Regulation: 21 CFR 878.4820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
50 later devices descend from it; 4 cite it directly.
0 of 51 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
- K032473: Dekompressor Percutaneous Discectomy Probe (2003), 28 descendants of its own
- K974464: Oratec Spinecath Intradiscal Catheter (1998), 20 descendants of its own
- K040919: Nucleotome Probe Set, Model 21200 (2004), 17 descendants of its own
- K993854: Ora-50 S Autotemp Electrothermal Spine System and Accessories (1999), 16 descendants of its own
- K062038: X-Sten Mild Tool Kit, Model MTK-0001 (2006), 14 descendants of its own

Source page: https://510kreport.com/device/K942987
Methodology: https://510kreport.com/methodology