|
|
| Device |
system, surgical, computer controlled instrument |
| Regulation Description |
Endoscope and accessories. |
| Definition |
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). |
| Product Code | NAY |
| Regulation Number |
876.1500
|
|---|
| Device Class |
2
|
| Recalls |
| Manufacturer |
Recall Class |
Date Posted |
| 1 |
Asensus Surgical Inc |
I |
Oct-30-2023 |
| 2 |
Intuitive Surgical Inc |
II |
May-05-2020 |
| 3 |
Intuitive Surgical, Inc. |
II |
Mar-12-2025 |
| 4 |
Intuitive Surgical, Inc. |
II |
Jan-16-2025 |
| 5 |
Intuitive Surgical, Inc. |
II |
Jan-10-2025 |
| 6 |
Intuitive Surgical, Inc. |
II |
Apr-11-2024 |
| 7 |
Intuitive Surgical, Inc. |
II |
Nov-28-2023 |
| 8 |
Intuitive Surgical, Inc. |
II |
Jun-30-2023 |
| 9 |
Intuitive Surgical, Inc. |
II |
Mar-28-2023 |
| 10 |
Intuitive Surgical, Inc. |
II |
Mar-16-2023 |
| 11 |
Intuitive Surgical, Inc. |
II |
Nov-30-2022 |
| 12 |
Intuitive Surgical, Inc. |
II |
Oct-25-2022 |
| 13 |
Intuitive Surgical, Inc. |
II |
Aug-01-2022 |
| 14 |
Intuitive Surgical, Inc. |
II |
Jul-25-2022 |
| 15 |
Intuitive Surgical, Inc. |
II |
May-31-2022 |
| 16 |
Intuitive Surgical, Inc. |
II |
Apr-22-2022 |
| 17 |
Intuitive Surgical, Inc. |
II |
Mar-01-2022 |
| 18 |
Intuitive Surgical, Inc. |
II |
Dec-27-2021 |
| 19 |
Intuitive Surgical, Inc. |
II |
Nov-23-2021 |
| 20 |
Intuitive Surgical, Inc. |
II |
Oct-23-2020 |
| 21 |
Intuitive Surgical, Inc. |
II |
Jun-03-2020 |
| 22 |
Intuitive Surgical, Inc. |
II |
Jun-01-2020 |
| 23 |
Intuitive Surgical, Inc. |
II |
May-11-2020 |
| 24 |
Intuitive Surgical, Inc. |
II |
May-06-2020 |
| 25 |
Intuitive Surgical, Inc. |
II |
Feb-06-2020 |
| 26 |
Intuitive Surgical, Inc. |
II |
Jan-31-2020 |
| 27 |
Intuitive Surgical, Inc. |
II |
Jan-24-2020 |
| 28 |
Olympus Corporation of the Americas |
II |
Jun-28-2024 |
|
|
|
|
