# K133198: Ultrapro Comfort Plug

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: May 30, 2014 after 225 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 K922916 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070224: Ultrapro Plug, ETHICON, Inc. (2007) Summary page 1.
- K922916: Bard Marlex Mesh Dart, C.R. Bard, Inc. (1992) Summary page 1.

## Indications for use
The ULTRAPRO COMFORT PLUGTM Partially Absorbable Hernia Repair Device is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.

Source page: https://510kreport.com/device/K133198
Methodology: https://510kreport.com/methodology