# K982532: Parietex

- Pathway: 510(k) (Traditional)
- Applicant: Cogent
- Decided: Jan 20, 1999 after 184 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.
18 later devices descend from it; 3 cite it directly.
0 of 19 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) Mersilene®: named in the summary without a submission number
- (no number) Ercylene®: named in the summary without a submission number
- (no number) Prolene®: named in the summary without a submission number
- (no number) Surgipre®: named in the summary without a submission number
- (no number) Marlex®: named in the summary without a submission number
- (no number) Visilex@: named in the summary without a submission number
- (no number) Atrium®: named in the summary without a submission number

## 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

## Indications for use
PARIETEX™T™ ProSup™ mesh; slings or pre-cut implants are intended for the repair of Inguinal and Incisional hernias, genito-urinary and rectal prolapses by promontofixation via open abdominal or laparoscopic approach. No applications other than the ones indicated are recommended.

Source page: https://510kreport.com/device/K982532
Methodology: https://510kreport.com/methodology