# K963141: Kugel Hernia Patch

- Pathway: 510(k) (Traditional)
- Applicant: Douglas Bueschel
- Decided: Oct 11, 1996 after 59 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.
12 later devices descend from it; 2 cite it directly.
0 of 13 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) Atrium Polypropylene Mesh: named in the summary without a submission number

## Most influential descendants
- K063671: Rebound HRD (2007), 10 descendants of its own
- K092726: Mesh GPS - Large, Small, SM, SM Small (2010), 7 descendants of its own
- K102766: Composix L/P Mesh with Echo PS Positioning System (2010), 6 descendants of its own
- K110820: Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System (2011), 5 descendants of its own
- K122436: Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS Positioning System (2012), 4 descendants of its own

## Indications for use
The intended use of the Kugel Hernia Patch™ is a surgical mesh for hernia repair. It is indicated for use in all forms of hernia repair. A few examples of hernia repair are Inguinal, Fermoral, Incisional and Ventral hernia repairs in the abdominal wall and the groin area.

Source page: https://510kreport.com/device/K963141
Methodology: https://510kreport.com/methodology