|
Device |
endoscope introducer kit |
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 kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market. |
Product Code | NWU |
Regulation Number |
876.1500
|
Device Class |
2
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
American Contract Systems, Inc. |
II |
Oct-26-2023 |
2 |
American Contract Systems, Inc. |
II |
Sep-08-2022 |
3 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Sep-11-2024 |
4 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Sep-06-2024 |
5 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Aug-22-2024 |
6 |
MEDLINE INDUSTRIES, LP - Northfield |
I |
Feb-25-2024 |
7 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Aug-03-2023 |
8 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Jul-20-2023 |
9 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Feb-06-2023 |
10 |
Merit Medical Systems, Inc. |
II |
Aug-12-2024 |
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