Device product
Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y
Z-1840-2026
Product summary
- Event
- Event 98599
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 75 units
- Official record key
device-enforcement:Z-1840-2026
Official wording
Reason: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Code information: 1) CDS930027Y, UDI-DI: 10198459303128(each), 40198459303129(case), Lot Number: 25EBE671
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.