# K042359: Subdural Evacuating Port System Cranial Access Kit (Seps-CA), (Seps-Cal), (Seps-Cand),Models 11-0401 CA, 11-0401-Cal

- Pathway: 510(k) (Traditional)
- Applicant: Medical Designs, LLC
- Decided: Nov 17, 2004 after 78 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K915546 (1991). 2 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K002970: Subdural Evacuating Port System, Model 11-9901, Medical Designs, LLC (2000) Summary page 1.
- K915546: PS Medical Ventriculostomy Kit, Pudenz-Schulte Medical Research Corp. (1991) Summary page 1.
- (no number) Cranial Access Kit: named in the summary without a submission number

## Most influential descendants
- K252514: Evac-Mri (2025), 0 descendants of its own
- K241458: Borvo EVAC System (Ergo); Borvo EVAC System (Classic) (2024), 0 descendants of its own

## Recalls of this device
- Nov 26, 2013 · Class II · Z-0551-2014: Integra LifeSciences is voluntarily recalling any unexpired lots of HITHSP10 Cranial Access Kits due to identified labeling discrepancies. kit contains DuraPrep and Monocryl sutures whose labeling doe

## Indications for use
Use of the Subdural Evacuating Port System Cranial Access Kit is indicated when access to and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Subdural Evacuating Port System Cranial Access Kit is intended for drainage of subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir. The Subdural Evacuating Port System Cranial Access Kit is also intended for draining air and fluids from the subdural space immediately following craniotomy procedures performed to remove a chronic or subacute subdural hematoma.

Source page: https://510kreport.com/device/K042359
Methodology: https://510kreport.com/methodology