Insightra Medical Inc
FDA Regulatory Profile
Insightra Medical Inc appears in FDA public data with 1 recall, 4 510(k) clearances, 4 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-2298-2025, Class II) was initiated on July 19, 2025. Its most recent 510(k) clearance was granted on May 7, 2015.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 4
- Inspections
- 4
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2298-2025 | Class II | Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IM | July 19, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K142192 | Insightra Freedom Ventral Hernia Repair System | May 7, 2015 |
| K140967 | FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK | June 10, 2014 |
| K113552 | FREEDOM INGUINAL HERNIA IMPLANT | August 23, 2012 |
| K082746 | ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 | January 12, 2009 |