510(k) K113552
K113552 is an FDA 510(k) premarket notification submitted by Insightra Medical for the device "FREEDOM INGUINAL HERNIA IMPLANT". The FDA issued a decision of Substantially Equivalent on August 23, 2012. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Insightra Medical has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 2012
- Date Received
- December 1, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Polymeric
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type