# K050969: Inclose Surgical Mesh System

- Pathway: 510(k) (Traditional)
- Applicant: Anulex Technologies, Inc.
- Decided: Aug 18, 2005 after 122 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K851086 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922916: Bard Marlex Mesh Dart, C.R. Bard, Inc. (1992) Summary page 1.
- K851086: Vicryl (Polyglactin 910/Mersilene Compoisite Mesh, ETHICON, Inc. (1985) Summary page 1.

## Indications for use
The mesh may be used to support soft tissue where weakness exists, or for the repair of hernias requiring the addition of a reinforcing, or bridging material, such as the repair of groin hernias.

Source page: https://510kreport.com/device/K050969
Methodology: https://510kreport.com/methodology