# K033671: Gore Bioabsorbable Mesh

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Dec 31, 2003 after 37 days
- Product code: OWT (Mesh, Surgical, Absorbable, Abdominal Hernia)
- 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: 6 generations back to K842066 (1985). 38 ancestors in all.
39 later devices descend from it; 7 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030782: Seamguard Bioabsorbable Staple Line Reinforcement Material, W. L. Gore & Associates, Inc. (2003) Summary page 2.
- K013346: Gore Drapeable ST/LT Regenerative Membrane, W. L. Gore & Associates, Inc. (2001) Summary page 2.
- K810428: Vicryl, ETHICON, Inc. (1981) Summary page 3.
- K001738: Depuy Restore Orthobiologic Soft Tissue Implant, DePuy Orthopaedics, Inc. (2000) Summary page 3.
- K021105: Fortaflex Surgical Mesh, Organogenesis, Inc. (2002) Summary page 3.

## Most influential descendants
- K071016: Depuy Restore Orthobiologic Soft Tissue Implant (2007), 13 descendants of its own
- K083266: Gore Bio-a Fistula Plug (2009), 12 descendants of its own
- K073219: WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6 CM X 8 CM, Model 89XM-6X08 (2008), 12 descendants of its own
- K120019: Collagen Ribbon (2012), 11 descendants of its own
- K132397: Gore Bio-a Wound Matrix (2014), 10 descendants of its own

## Indications for use
The GORE BIOABSORBABLE MESH is intended for use in the reinforcement of soft tissue. Examples of applications where the GORE BIOABSORBABLE MESH may be used include, but are not limited to: Hernia repair (inguinal, femoral, umbilical, abdominal, diaphragmatic, incisional, epigastric, gastroesophageal, hiatal, intermuscular). Muscle flap reinforcement Perforated tissue repair General tissue reconstruction’s (periosteum, thoracic wall, reinforcement of the bladder wall, suture line reinforcement, tissue deficit, etc.)

Source page: https://510kreport.com/device/K033671
Methodology: https://510kreport.com/methodology