# K180910: ULTRAPRO Mesh and ULTRAPRO ADVANCED

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Jul 2, 2018 after 87 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: 2 generations back to K033337 (2004). 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)
- K033337: Ultrapro Mesh, ETHICON, Inc. (2004) Summary page 5.
- K150906: ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh, Ehicon, Inc. (2015) Summary page 5.

## Indications for use
ULTRAPRO™ Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result. ULTRAPRO ADVANCED™ Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.

Source page: https://510kreport.com/device/K180910
Methodology: https://510kreport.com/methodology