# K960470: Neuro-Patch

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: May 10, 1996 after 99 days
- Product code: GXQ (Dura Substitute)
- Device class: 2
- Regulation: 21 CFR 882.5910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dura Film: named in the summary without a submission number
- (no number) Preclude Dura Substitute: named in the summary without a submission number
- (no number) Tutoplast® Dura substitute: named in the summary without a submission number
- (no number) Dura-Guard™ Dural Repair Patch: named in the summary without a submission number

## Most influential descendants
- K991413: Codman Ethisorb Dura Patch (2000), 14 descendants of its own
- K153613: Cerafix Dura Substitute (2016), 7 descendants of its own
- K161278: Cerafix Dura Substitute (2016), 6 descendants of its own
- K170300: Restrata Wound Matrix (2017), 4 descendants of its own
- K033395: Codman Dural Graft Implant, Models 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1 (2004), 2 descendants of its own

## Indications for use
Neuro-Patch (like its predicate devices) is indicated as a dura mater substitute in neurological procedures for soft tissue reconstruction of damaged, impaired, or missing tissue.

Source page: https://510kreport.com/device/K960470
Methodology: https://510kreport.com/methodology