Freedom – ProFlor Inguinal Hernia Kit
The Freedom ProFlor Inguinal Hernia Kit provides an implant and delivery device for open repair of an inguinal hernia. The implant reinforces weakened soft tissue at the hernia opening. The…
The Freedom ProFlor Inguinal Hernia Kit provides an implant and delivery device for open repair of an inguinal hernia. The implant reinforces weakened soft tissue at the hernia opening.
The polypropylene implant combines a looped core that fills the opening with an underlay mesh patch that reinforces the defect and helps retain the implant. The delivery device compacts the implant and guides it into the prepared defect, where surrounding tissue grips it.
Listed Item
The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile, polypropylene implant device designed for use in the open repair of inguinal hernias. A delivery device is used to deploy the implant into the prepared hernia defect site.
Presentation
Two implant sizes have corresponding delivery devices for different defect sizes. Both implant and delivery device are supplied sterile for use in one patient.
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Suokang Medical Implants Co., Ltd. | Shang Hai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Insightra Medical, Inc., United States |
|---|---|
| FDA product code | FTL |
| Device type | Mesh, Surgical, Polymeric |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K113552 |
| Record published | 2015-07-22 |
| Record revised | 2022-06-10 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 6 |
| Sizes | Outer diameter 25 to 40 mm |
| Distribution end date | 2019-12-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FIHR 40mmK | Outer Diameter 40 mm | Withdrawn |
| FIHR 40mmEK | Outer Diameter 40 mm | Withdrawn |
| FIHR 25mmK | Outer Diameter 25 mm | Withdrawn |
| FIHR 25mmEK | Outer Diameter 25 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Technical Products | Technical Products, Inc. | 143 |
| Parietex | Sofradim Production | 82 |
| DynaMesh | FEG Textiltechnik Forschungs- und Entwicklungsges. mbH | 45 |
| Symbotex | Sofradim Production | 35 |
| Silicone Sheeting Reinforced | Bentec Medical OpCo, LLC. | 33 |
| Parietene | Sofradim Production | 32 |
| C-QUR | Atrium Medical Corporation | 31 |
| ProGrip | Sofradim Production | 31 |
| Silicone Sheeting Non-Reinforced | Bentec Medical OpCo, LLC. | 31 |
| Prolite | Atrium Medical Corporation | 31 |
| Gore Seamguard Bioabsorbable Staple Line Reinforce | W. L. Gore & Associates, Inc. | 30 |
| Surgimesh®wn | Aspide Medical | 28 |
Showing 12 of 148. All products under Mesh, Surgical, Polymeric
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142192 | 2015-05-07 |
| K140967 | 2014-06-10 |
| K113552 | 2012-08-23 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P990028 | 2003-12-04 | FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT | Genzyme Corporation |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.