# K033337: Ultrapro Mesh

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Apr 1, 2004 after 167 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
No predicates in its family tree.
82 later devices descend from it; 9 cite it directly.
0 of 83 devices 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) VYPRO Mesh: named in the summary without a submission number
- (no number) PROLENE Polypropylene Mesh: named in the summary without a submission number
- (no number) MERSILENE Mesh: named in the summary without a submission number

## Most influential descendants
- K052830: Sportmesh (2006), 44 descendants of its own
- K071887: Sportmesh or Artelon Tissue Reinforcement (2007), 28 descendants of its own
- K071512: Gynecare Prolift +M* Pelvic Floor Repair Systems (2008), 20 descendants of its own
- K070961: Biomerix Surgical Mesh, Model: RCR-01 (2008), 17 descendants of its own
- K092207: Restorelle Polypropylene Mesh (2009), 13 descendants of its own

## Indications for use
Is for the "repair ofhemias and other abdominalfascial deficiencies that requie the addition of a reinforcing or bridging maedl to obtain the desired surgical rcsult."

Source page: https://510kreport.com/device/K033337
Methodology: https://510kreport.com/methodology