Product code PTW
- Device name
- System, Peritoneal, Automatic Delivery, Exempt
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5630
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- This product code is the class II exempt counterpart of FKX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.
- Source
- FDA openFDA device classification dataset