# K031225: Timesh Also Known as Timesh-TC, Models 6000001 & 6000004

- Pathway: 510(k) (Traditional)
- Applicant: Gfe Medizintechnik GmbH
- Decided: Sep 29, 2003 after 165 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.
42 later devices descend from it; 3 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 3 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K001122: Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh, ETHICON, Inc. (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K905655: Nonabsorbable Polypropylene Surgical Mesh, United States Surgical, A Division of Tyco Healthc (1990). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K915526: Coated Surgipro (TM) Polypropylene Surgical Mesh, United States Surgical, A Division of Tyco Healthc (1992). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K050332: Surgi-Wrap Mast Bioresorbable Sheet (2005), 36 descendants of its own
- K070894: Tephaflex Surgical Mesh (2007), 17 descendants of its own
- K061473: Surgi-Wrap Mast Bioresorbable Sheet (2006), 13 descendants of its own
- K063648: Surgi-Wrap Mast Tendon Sheet (2007), 12 descendants of its own
- K072190: Ortho-Wrap Bioresorbable Sheet (2008), 10 descendants of its own

## Indications for use
The TIMESH is intended for the reinforcement of tissue during surgical repair. Specifically, the TiIMESH is indicated for laparoscopic and open surgery for the repair of direct inguinal hemias, indirect inguinal hernias, femoral hemias, umbilical hernias, incisional hernias, parietal reinforcement of tissues and abdominal wall repair.

Source page: https://510kreport.com/device/K031225
Methodology: https://510kreport.com/methodology