The following data is part of a premarket notification filed by Insightra Medical with the FDA for Insightra Freedom Ventral Hernia Repair System.
| Device ID | K142192 |
| 510k Number | K142192 |
| Device Name: | Insightra Freedom Ventral Hernia Repair System |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Insightra Medical 9200 Irvine Center Drive Suite 200 Irvine, CA 92618 |
| Contact | Neerav Parikh |
| Correspondent | Neerav Parikh Insightra Medical 9200 Irvine Center Drive Suite 200 Irvine, CA 92618 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-11 |
| Decision Date | 2015-05-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850012832348 | K142192 | 000 |
| 00837654352991 | K142192 | 000 |
| 00837654352984 | K142192 | 000 |
| 00850012832256 | K142192 | 000 |
| 00837654352960 | K142192 | 000 |