|
|
| Device |
laparoscopy kit |
| Regulation Description |
Endoscope and accessories. |
| Definition |
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. |
| Product Code | FDE |
| Regulation Number |
876.1500
|
|---|
| Device Class |
2
|
| Recalls |
| Manufacturer |
Recall Class |
Date Posted |
| 1 |
American Contract Systems |
II |
May-29-2020 |
| 2 |
American Contract Systems Inc |
II |
Aug-28-2025 |
| 3 |
American Contract Systems Inc |
II |
Mar-14-2025 |
| 4 |
American Contract Systems Inc. |
II |
Oct-16-2025 |
| 5 |
American Contract Systems, Inc. |
II |
Mar-21-2025 |
| 6 |
American Contract Systems, Inc. |
II |
Sep-24-2024 |
| 7 |
American Contract Systems, Inc. |
II |
Aug-07-2024 |
| 8 |
American Contract Systems, Inc. |
II |
Jan-26-2024 |
| 9 |
American Contract Systems, Inc. |
II |
Oct-26-2023 |
| 10 |
American Contract Systems, Inc. |
II |
Sep-08-2022 |
| 11 |
American Contract Systems, Inc. |
II |
May-06-2022 |
| 12 |
Cardinal Health 200, LLC |
II |
Oct-10-2023 |
| 13 |
DeRoyal Industries Inc |
II |
Nov-05-2024 |
| 14 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Aug-28-2025 |
| 15 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
May-01-2025 |
| 16 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Apr-17-2025 |
| 17 |
MEDLINE INDUSTRIES, LP - Northfield |
I |
Apr-04-2025 |
| 18 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Mar-25-2025 |
| 19 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Mar-14-2025 |
| 20 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Dec-30-2024 |
| 21 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Dec-20-2024 |
| 22 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Nov-26-2024 |
| 23 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Dec-05-2024 |
| 24 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Oct-23-2024 |
| 25 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Oct-10-2024 |
| 26 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Sep-11-2024 |
| 27 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Sep-06-2024 |
| 28 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Aug-28-2024 |
| 29 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Aug-22-2024 |
| 30 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Jun-28-2024 |
| 31 |
MEDLINE INDUSTRIES, LP - Northfield |
I |
Feb-25-2024 |
| 32 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Aug-03-2023 |
| 33 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Jul-20-2023 |
| 34 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Feb-06-2023 |
| 35 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Jan-27-2023 |
| 36 |
MEDLINE INDUSTRIES, LP - SPT |
II |
Jul-27-2022 |
| 37 |
Medline Industries Inc |
II |
Jan-07-2021 |
| 38 |
Medline Industries Inc |
II |
Feb-11-2020 |
| 39 |
ROi CPS LLC |
II |
Apr-25-2023 |
| 40 |
ROi CPS LLC |
II |
Nov-23-2022 |
| 41 |
ROi CPS LLC |
II |
Jun-08-2022 |
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