Medline Hysteroscopy and Sling Packs subject to regulatory rescission
FDA has rescinded 510(k) regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing components in two Medline medical device kits distributed nationwide.
- Product
- Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model Number: DYNJ62849B
- Category
- Medical Device
- Distribution
- Distributed nationwide