Asensus Surgical Israel Ltd.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3038284218 | 3038284218 | Asensus Surgical Israel Ltd. | 1 | N | 2026-01-01 | HaKadima, St. 9, Fibernet building, Floor #4 Yokne'am Illit Northern IL 2069206 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 339936 | 1707628402 | K254192 | Senhance Ultrasonic System | NAY | 2026-05-12 |
| 339936 | 1322433395 | K233866 | Senhance Surgical System | NAY | 2024-07-19 |
| 339936 | 1608309205 | K223095 | Senhance Surgical System | NAY | 2023-03-16 |
| 339936 | 2001495241 | K220889 | Senhance Surgical System | NAY | 2022-05-27 |
| 339936 | 1380662247 | K212054 | Senhance Surgical System | NAY | 2021-08-30 |
| 339936 | 1552019646 | K211325 | Senhance Surgical System | NAY | 2021-07-27 |
| 339936 | 1979437519 | K202166 | Senhance Surgical System | NAY | 2021-03-02 |
| 339936 | 1649245516 | K200049 | Senhance Surgical System | NAY | 2020-03-09 |
| 339936 | 1140106566 | K192877 | Senhance Surgical System | NAY | 2019-11-22 |
| 339936 | 1860352575 | K191482 | Senhance Surgical System | NAY | 2019-07-11 |
| 339936 | 2012085030 | K182421 | Senhance Ultrasonic System | NAY | 2019-01-11 |
| 339936 | 1076899879 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| NAY | 11 | 2026-05-12 |