# K930591: TI-Cron and Dacron Sutures

- Pathway: 510(k) (Traditional)
- Applicant: Davis & Geck, Inc.
- Decided: Dec 17, 1993 after 316 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 5 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K081050: Parietex Progrip Mesh (2008), 15 descendants of its own
- K103682: Parietex Progrip (2011), 6 descendants of its own
- K101519: Parietex Plug and Patch (2010), 6 descendants of its own
- K101197: Parie Tene Progrip Mesh (2010), 6 descendants of its own
- K142900: Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh (2014), 5 descendants of its own

## Recalls of this device
- Jun 3, 2011 · Not classified · Z-2825-2011: Potential for the sterile barrier to be breached compromising the sterility of the product
- Jun 3, 2011 · Not classified · Z-2827-2011: Potential for the sterile barrier to be breached compromising the sterility of the product
- Jun 3, 2011 · Not classified · Z-2830-2011: Potential for the sterile barrier to be breached compromising the sterility of the product
- Jun 3, 2011 · Not classified · Z-2826-2011: Potential for the sterile barrier to be breached compromising the sterility of the product
- Jun 3, 2011 · Not classified · Z-2829-2011: Potential for the sterile barrier to be breached compromising the sterility of the product
- Jun 3, 2011 · Not classified · Z-2828-2011: Potential for the sterile barrier to be breached compromising the sterility of the product

Source page: https://510kreport.com/device/K930591
Methodology: https://510kreport.com/methodology