# K002970: Subdural Evacuating Port System, Model 11-9901

- Pathway: 510(k) (Traditional)
- Applicant: Medical Designs, LLC
- Decided: Dec 12, 2000 after 81 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K042359: Subdural Evacuating Port System Cranial Access Kit (Seps-CA), (Seps-Cal), (Seps-Cand),Models 11-0401 CA, 11-0401-Cal (2004), 2 descendants of its own
- K252514: Evac-Mri (2025), 0 descendants of its own
- K241458: Borvo EVAC System (Ergo); Borvo EVAC System (Classic) (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K002970
Methodology: https://510kreport.com/methodology