# K013231: Avid-Nit Plastic Hub Lutz Epidural Needle,Model RP2035L, Avid-Nit Metal Hub Lutz Epidural Needle, Model RM2035L

- Pathway: 510(k) (Traditional)
- Applicant: Avid N.I.T., Inc.
- Decided: Dec 3, 2001 after 67 days
- Product code: BSP (Needle, Conduction, Anesthetic (W/Wo Introducer))
- Device class: 2
- Regulation: 21 CFR 868.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Avid-NIT Lutz Needle is used for the percutaneous puncture of the back, over the spine and into the epidural space for the single shot injection of anesthetic agents. This needle is not intended for use with an epidural catheter.

Source page: https://510kreport.com/device/K013231
Methodology: https://510kreport.com/methodology