The following data is part of a premarket notification filed by Via Surgical Ltd. with the FDA for Tissuetak Device.
| Device ID | K203117 |
| 510k Number | K203117 |
| Device Name: | TissueTak Device |
| Classification | Staple, Implantable |
| Applicant | Via Surgical Ltd. Mitzpe Kineret Street 22/1 Amirim, IL 2011500 |
| Contact | Ofek Levin |
| Correspondent | Orly Maor Orly Maor 25A Sirkin Street Kfar Saba, IL 4442156 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-16 |
| Decision Date | 2021-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290017155347 | K203117 | 000 |
| 17290017155309 | K203117 | 000 |
| 07290017155357 | K203117 | 000 |
| 07290017155364 | K203117 | 000 |