510(k) K173796 · FTL Mesh, Surgical, Polymeric
Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)
| Applicant | Sofradim Production, Trévoux, FR |
| Decision | Substantially Equivalent, Mar 9, 2018 |
| Received | Dec 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173796
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2023 | Covidien, LP Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe-
Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement of tissues during surgical repair
Model Number: PCO2H3 Open, Classified |
FTL | None listed |
| Jan 13, 2021 | Covidien Llc Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias via laparoscopic or posterior open procedures Item Code: TECT151 Terminated |
FTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.