# Insightra Medical

- Location (FDA's records): Irvine, CA
- FDA decisions: 4 (2009–2015): 4 510(k) clearances
- Names in FDA's records: Insightra Medical (3); Insightra Medical, Inc. (1)
- Product codes: FTL (3), DSP (1)
- Predicates its devices cite: 9 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- ETHICON, Inc.: 2 (https://510kreport.com/company/ethicon)
- C.R. Bard, Inc.: 2 (https://510kreport.com/company/cr-bard)
- Atrium Medical Corp.: 1 (https://510kreport.com/company/atrium-medical)
- United States Surgical, A Division of Tyco Healthc: 1 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)
- Abiomed, Inc.: 1 (https://510kreport.com/company/abiomed)
- Datascope Corp.: 1 (https://510kreport.com/company/datascope)

## Its most-cited devices
- K113552: Freedom Inguinal Hernia Implant (2012), cited by 1

## Recent decisions
- K142192: Insightra Freedom Ventral Hernia Repair System (May 7, 2015)
- K140967: Freedom Inguinal Hernia Repair Implant-25MM/40MM/40MM with Extended Disk (Jun 10, 2014)
- K113552: Freedom Inguinal Hernia Implant (Aug 23, 2012)
- K082746: Ultra Iabp Catheter Kit, Models IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 (Jan 12, 2009)

Source page: https://510kreport.com/company/insightra-medical