The following data is part of a premarket notification filed by Invasix Ltd. with the FDA for Fractora.
| Device ID | K102461 |
| 510k Number | K102461 |
| Device Name: | FRACTORA |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | INVASIX LTD. APOLO BUILDING POB 533 Yokneam Illit, IL 20692 |
| Contact | Amir Waldman |
| Correspondent | Amir Waldman INVASIX LTD. APOLO BUILDING POB 533 Yokneam Illit, IL 20692 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-27 |
| Decision Date | 2011-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016633054 | K102461 | 000 |
| 07290016633023 | K102461 | 000 |
| 17290016633181 | K102461 | 000 |
| 17290016633174 | K102461 | 000 |