FLASH EVD System (10-0002)
7D Surgical ULC
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012098629 | 3012098629 | 7D SURGICAL ULC | 1 | N | 2026-01-01 | 60 Scarsdale Road, Unit 118 Toronto Ontario CA M3B 2R7 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 203492 | 1955279651 | K242480 | FLASH EVD System (10-0002) | HAW | 2024-12-27 |
| 203492 | 1788878452 | K220522 | 7D Surgical System - Percutaneous Application (7D Flash Frame) | OLO | 2022-05-20 |
| 203492 | 1121118472 | K210555 | 7D Surgical System - Drill Guide | OLO | 2021-03-23 |
| 203492 | 1284571004 | K210457 | 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key | OLO | 2021-06-21 |
| 203492 | 1490723661 | K201966 | 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array | OLO | 2020-09-03 |
| 203492 | 1990404148 | K192945 | 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application | HAW | 2019-11-27 |
| 203492 | 1259830624 | K192140 | 7D Surgical System | OLO | 2019-11-05 |
| 203492 | 1141514117 | K183276 | 7D Surgical System | HAW | 2019-08-07 |
| 203492 | 1464034733 | K181041 | 7D Surgical System Cranial Application | HAW | 2018-08-08 |
| 203492 | 1542627887 | K180352 | 7D Surgical System | OLO | 2018-05-02 |
| 203492 | 1513441296 | K162375 | Envision 3D: Image Guidance System | OLO | 2016-12-29 |
7D Surgical ULC
2026-04-08
2026-04-08
2026-04-08
2026-04-08
2025-09-17
2025-07-28
2025-07-28
2023-02-21
2023-02-21
2021-07-27
2021-07-27
2024-07-19
2023-01-12
2023-08-18
2023-07-31
2022-09-21
2022-09-21
2022-09-21
2020-11-18
2022-01-11
2021-12-31
2021-12-31
2021-12-31
2021-02-12
2021-01-06
2020-10-21
2020-10-21
2020-10-21
2020-10-21
2020-10-21
2020-05-04
2020-05-04
2020-05-04
2019-11-26
2019-11-26
2019-11-26
2019-11-26
2019-11-26
2020-01-14
2019-12-17