|
Device |
system, surgical, computer controlled instrument |
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
|
MDR Year |
MDR Reports |
MDR Events |
2019 |
1154 |
1154 |
2020 |
1558 |
1558 |
2021 |
1997 |
1997 |
2022 |
5728 |
5728 |
2023 |
10899 |
10899 |
2024 |
11670 |
11670 |
|
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 |
Apr-11-2024 |
4 |
Intuitive Surgical, Inc. |
II |
Nov-28-2023 |
5 |
Intuitive Surgical, Inc. |
II |
Jun-30-2023 |
6 |
Intuitive Surgical, Inc. |
II |
Mar-28-2023 |
7 |
Intuitive Surgical, Inc. |
II |
Mar-16-2023 |
8 |
Intuitive Surgical, Inc. |
II |
Nov-30-2022 |
9 |
Intuitive Surgical, Inc. |
II |
Oct-25-2022 |
10 |
Intuitive Surgical, Inc. |
II |
Aug-01-2022 |
11 |
Intuitive Surgical, Inc. |
II |
Jul-25-2022 |
12 |
Intuitive Surgical, Inc. |
II |
May-31-2022 |
13 |
Intuitive Surgical, Inc. |
II |
Apr-22-2022 |
14 |
Intuitive Surgical, Inc. |
II |
Mar-01-2022 |
15 |
Intuitive Surgical, Inc. |
II |
Dec-27-2021 |
16 |
Intuitive Surgical, Inc. |
II |
Nov-23-2021 |
17 |
Intuitive Surgical, Inc. |
II |
Oct-23-2020 |
18 |
Intuitive Surgical, Inc. |
II |
Jun-03-2020 |
19 |
Intuitive Surgical, Inc. |
II |
Jun-01-2020 |
20 |
Intuitive Surgical, Inc. |
II |
May-11-2020 |
21 |
Intuitive Surgical, Inc. |
II |
May-06-2020 |
22 |
Intuitive Surgical, Inc. |
II |
Feb-06-2020 |
23 |
Intuitive Surgical, Inc. |
II |
Jan-31-2020 |
24 |
Intuitive Surgical, Inc. |
II |
Jan-24-2020 |
25 |
Intuitive Surgical, Inc. |
II |
Oct-30-2019 |
26 |
Intuitive Surgical, Inc. |
II |
Feb-15-2019 |
27 |
Olympus Corporation of the Americas |
II |
Jun-28-2024 |
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