Product code PIO
- Device name
- Enteral Specific Transition Connectors
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5980
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231299 | Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector | Cair Lgl | 2024-01-22 |
| K233190 | ENFit Adaptor | Jiangsu Caina Medical Co.,Ltd | 2024-01-18 |
| K220165 | Enteral Transition Adaptor | GBUK Group, Ltd. | 2022-10-21 |
| K162254 | Cedic Enteral ENFit Transition Connectors | Cedic S.R.L. | 2017-05-04 |
| K151237 | Nutrisafe 2- ENFit Adaptor | Vygon | 2016-02-09 |
| K151628 | Medline ENFit Connectors | Medline Industries, Inc. | 2015-07-24 |
| K150034 | AMT Enteral Transition Adapters | Applied Medical Technology, Inc. | 2015-06-09 |
| K150010 | Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port | Cedic S.R.L. | 2015-04-02 |
| K140581 | CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT | Cedic S.R.L. | 2014-10-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00842071133290 | ENFit Transition Adapter | APPLIED MEDICAL TECHNOLOGY, INC. | 2025-05-28 |
| 00842071133283 | ENFit Transition Adapter | APPLIED MEDICAL TECHNOLOGY, INC. | 2025-05-28 |
| 00842071133276 | ENFit Transition Adapter | APPLIED MEDICAL TECHNOLOGY, INC. | 2025-05-28 |
| 00842071133269 | ENFit Transition Adapter | APPLIED MEDICAL TECHNOLOGY, INC. | 2025-05-28 |
| 00842071133252 | ENFit Transition Adapter | APPLIED MEDICAL TECHNOLOGY, INC. | 2025-05-28 |
| 00842071133245 | ENFit Transition Adapter | APPLIED MEDICAL TECHNOLOGY, INC. | 2025-05-28 |
| 10192253009644 | Kangaroo | Cardinal Health 200, LLC | 2024-03-26 |
| 10888277314719 | Medline | MEDLINE INDUSTRIES, INC. | 2022-12-02 |
| 10884389196915 | Medline | MEDLINE INDUSTRIES, INC. | 2020-12-17 |
| 08056093720563 | ENConnect Male Distal End Stepped Adapter | CEDIC SRL | 2019-01-29 |
| 08056093720594 | ENConnect ENFit Funnel Adapter | CEDIC SRL | 2019-01-29 |
| 08056093720686 | ENConnect ENFit to Oral/Luer syringe adapter | CEDIC SRL | 2019-01-29 |
| 00857915006128 | EnsoETM | Advanced Cooling Therapy, LLC | 2018-09-08 |
| 08056093720297 | Enteral Funnel ENFIt Transition Connector with cap | CEDIC SRL | 2018-07-03 |
| 00857915006203 | EnsoETM | Advanced Cooling Therapy, LLC | 2018-05-17 |
| 08056093720327 | Enteral Distal End ENFit Transition Connector | CEDIC SRL | 2018-05-04 |
| 08056093720402 | Enteral Distal End ENFit Transition Connector with cap | CEDIC SRL | 2017-12-28 |
| 08056093720341 | Oral/Luer ENFit Transition Connector for medication port | CEDIC SRL | 2017-12-28 |
| 08056093720266 | Enteral Distal End ENFit Transition Connector | CEDIC SRL | 2017-12-28 |
| 08056093720143 | Enteral Funnel ENFit Transition Connector with cap | CEDIC SRL | 2017-12-28 |
| 08056093720112 | Enteral ENFit Transition Connector with cap for medication port | CEDIC SRL | 2017-12-28 |
| 08056093720051 | Luer to ENFit Transition Connector | CEDIC SRL | 2017-12-28 |
| 08056093720013 | ENFit to Reverse Luer Transition Connector | CEDIC SRL | 2017-12-28 |
| 08056093720082 | Enteral ENFit Transition Connector with cap for medication port | CEDIC SRL | 2016-11-18 |
| 00842071107994 | AMT Enfit® Transition Adapter | APPLIED MEDICAL TECHNOLOGY, INC. | 2016-08-31 |
| 00842071108007 | AMT Enfit® Transition Adapter | APPLIED MEDICAL TECHNOLOGY, INC. | 2016-08-31 |
| 00842071108014 | AMT Enfit® Transition Adapter | APPLIED MEDICAL TECHNOLOGY, INC. | 2016-08-31 |
| 00842071108021 | AMT Enfit® Transition Adapter | APPLIED MEDICAL TECHNOLOGY, INC. | 2016-08-31 |
| 00842071108038 | AMT Enfit® Transition Adapter | APPLIED MEDICAL TECHNOLOGY, INC. | 2016-08-31 |
| 00842071108052 | AMT Enfit® Transition Adapter | APPLIED MEDICAL TECHNOLOGY, INC. | 2016-08-31 |