PIO — Enteral Specific Transition Connectors Class II
Classification Details
- Product Code
- PIO
- Device Class
- Class II
- Regulation Number
- 876.5980
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K231299 | cair lgl | Nutricair enteral ENFit adapter: ENFit male stepped/Christmas tree connector | January 22, 2024 |
| K233190 | jiangsu caina medical co | ENFit Adaptor | January 18, 2024 |
| K220165 | gbuk group | Enteral Transition Adaptor | October 21, 2022 |
| K162254 | cedic | Cedic Enteral ENFit Transition Connectors | May 4, 2017 |
| K151237 | vygon | Nutrisafe 2- ENFit Adaptor | February 9, 2016 |
| K151628 | medline industries | Medline ENFit Connectors | July 24, 2015 |
| K150034 | applied medical technology | AMT Enteral Transition Adapters | June 9, 2015 |
| K150010 | cedic | Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port | April 2, 2015 |
| K140581 | cedic | CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSIT | October 17, 2014 |