# K033814: Bard Soft Mesh, Models 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Mar 1, 2004 after 83 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 3 cite it directly.
0 of 12 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) Bard Mesh (Davol Inc.): named in the summary without a submission number
- (no number) Atrium ProLite Ultra Mesh (Atrium Medical Corporation): named in the summary without a submission number
- (no number) Ethicon Mersilene Polyester Fiber Mesh (Ethicon, Inc.): named in the summary without a submission number

## Most influential descendants
- K061445: Surgimesh WN (2007), 5 descendants of its own
- K060237: CMB Antimicrobial Dressing (2006), 4 descendants of its own
- K081977: Prosit Wound Treatment Device (2008), 3 descendants of its own
- K072974: Surgimesh XB (2008), 3 descendants of its own
- K130350: Procellera (2013), 2 descendants of its own

## Recalls of this device
- Apr 25, 2011 · Not classified · Z-2239-2011: Mislabeling: complaints of product labeled as Bard Soft Mesh 4" x 6" containing Bard Soft Mesh 6" x 6"

## Indications for use
Indicated to reinforce soft tissue where weakness exists, i.e., repair of hernias and chest wall defects.

Source page: https://510kreport.com/device/K033814
Methodology: https://510kreport.com/methodology