# K973638: N.I.T., Inc. Needle Guiding Template

- Pathway: 510(k) (Traditional)
- Applicant: Avid N.I.T., Inc.
- Decided: Dec 23, 1997 after 90 days
- Product code: IWJ (System, Applicator, Radionuclide, Manual)
- Device class: 1
- Regulation: 21 CFR 892.5650
- 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 N.LT., Inc. Needle Guiding Template is a device with needle guidance holes in a grid coordinate system used to guide needles for the placement of radionuclide seeds into the body. The most common site of use is to place the template in proximity to, but not touching the perineum for seed placement into and around the prostate.

Source page: https://510kreport.com/device/K973638
Methodology: https://510kreport.com/methodology