Medline General Laparoscopy Kit regulatory clearance rescinded
The FDA has rescinded the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing components in Medline's General Laparoscopy Kit (Model CDS930027Y). Affected units should not be used.
- Product
- Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y
- Category
- Medical Device
- Distribution
- Distributed nationwide