Freedom Inguinal Hernia Repair IMPLANT-25MM/40MM/40MM With Extended Disk
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140967 FDA 510(k)
- FDA Product Code
- FTL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.3300 FDA 510(k)
- Regulation Number
- 878.3300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Freedom Inguinal Hernia Repair Implant-25mm/40mm/40mm With Extended Disk is a polymeric surgical mesh intended to reinforce soft tissues where weakness exists for open repair of inguinal hernias. It is classified as Mesh, Surgical, Polymeric under product code FTL and device class II with special controls.
The device is supplied as a sterile, single-use implant for use in general and plastic surgery settings. It received FDA 510(k) clearance under K140967 on June 10, 2014, and is manufactured by Insightra Medical, Inc. in Irvine, California.
Frequently asked questions
What is the Freedom Inguinal Hernia Repair Implant-25mm/40mm/40mm With Extended Disk used for?
It is a polymeric surgical mesh intended to reinforce soft tissues where weakness exists for open repair of inguinal hernias in general and plastic surgery settings.
How is the Freedom Inguinal Hernia Repair Implant supplied and is it reusable?
The device is supplied as a sterile, single-use implant, meaning it is designed for one-time use only and should not be reprocessed or reused.
What are the dimensions of the Freedom Inguinal Hernia Repair Implant-25mm/40mm/40mm With Extended Disk?
The implant has dimensions of 25mm by 40mm by 40mm and includes an extended disk as part of its design.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Freedom Inguinal Hernia Repair Implant-25mm/40mm/40mm With Extended Disk, K140967 FDA 510 (k) - FREEDOM INGUINAL HERNIA REPAIR IMPLANT-..., Freedom Inguinal Hernia Repair Implant-25mm/40mm/40mm With Extended ..., Freedom Inguinal Hernia Repair Implant-25mm/40mm/40mm With Extended ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140967 | Class II | Active |
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Manufacturer
- Manufacturer
- Insightra Medical, Inc.
- FDA Applicant
- Insightra Medical
Sources (1)
- FDA 510(k) K140967 24 fields · synced Oct 6, 2026