# K093279: Navix Access Device

- Pathway: 510(k) (Traditional)
- Applicant: Xlumena
- Decided: Apr 7, 2010 after 169 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K970053 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082114: Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00, Apollo Endosurgery, Inc. (2008) Summary page 1.
- K022595: Wilson-Cook Cystotome, Wilson-Cook Medical, Inc. (2002) Summary page 1.

## Recalls of this device
- Apr 17, 2013 · Class II · Z-2167-2013: A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.

Source page: https://510kreport.com/device/K093279
Methodology: https://510kreport.com/methodology