510(k) K233190
- Device
- ENFit Adaptor
- Applicant
- Jiangsu Caina Medical Co.,Ltd
- 510(k) number
- K233190
- Product code
- PIO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-01-18
- Date received
- 2023-09-28
- Regulation
- 876.5980
- Classification name
- Enteral Specific Transition Connectors
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Camel Zhou
- Address
- # 23, Huanxi Rd. Zhutang Town Jiangyin CN 214415 214415
FDA Registration Numbers
- 1417592
- 3014662855
- 1423537
- 3012494290
- 3011237770
- 8020785
- 3003593728
- 1526012
- 9612030
- 3007441619
- 3006673317
- 3036722184
- 3015433750
- 3004472854
- 3023275185
- 3012441761
- 3013788631
- 9611594
Source Documents
Other 510(k) Records For Product Code PIO
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231299 | Nutricair enteral ENFit adapter: ENFit male stepped/Christmas tree connector | Cair Lgl | 2024-01-22 |
| 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 |