# K983007: Neurotube

- Pathway: 510(k) (Traditional)
- Applicant: Neuroregen, LLC
- Decided: Mar 22, 1999 after 206 days
- Product code: JXI (Cuff, Nerve)
- Device class: 2
- Regulation: 21 CFR 882.5275
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 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) Silicone Nerve Cuffs: named in the summary without a submission number

## Most influential descendants
- K032115: Neurolac Nerve Guide Models NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 (2003), 5 descendants of its own
- K112267: Neurolac (R) Nerve Guide (2011), 3 descendants of its own
- K050573: Neurolac Nerve Guide (2005), 2 descendants of its own
- K152967: Nerbridge (2016), 1 descendant of its own
- K260245: SILKBridge (2026), 0 descendants of its own

## Recalls of this device
- Mar 27, 2023 · Class II · Z-1461-2023: The product is brittle and potentially crumbling upon handling or when being removed from its package.

## Indications for use
The Neurotube is intended for single use in patients with an injury to a peripheral nerve, in which the nerve gap is more than or equal to 8 mm but less than or equal to 3 cm. The nerve gap may be created primarily at the time of injury or created secondarily at the time of exploration of failed primary repair.

Source page: https://510kreport.com/device/K983007
Methodology: https://510kreport.com/methodology