# K972521: Navigator (Stylet) 2006

- Pathway: 510(k) (Traditional)
- Applicant: Sil-Med Corp.
- Decided: Oct 1, 1997 after 86 days
- Product code: GAH (Stylet, Surgical, General & Plastic Surgery)
- Device class: 1
- Regulation: 21 CFR 878.4800
- 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. The FDA summary names its predicate without a number.
- (no number) Accurate Surgical’s Insertion Stylet: named in the summary without a submission number
- (no number) Medigroup’s Catheter Stylettes: named in the summary without a submission number
- (no number) Quinton’s Stylet: named in the summary without a submission number

## Indications for use
The Navigator (stylet) is a stainless steel wire rod, inserted into the catheter to assist with insertion and placement of the catheter in the peritoneum.

Source page: https://510kreport.com/device/K972521
Methodology: https://510kreport.com/methodology