ENFit Adaptor
FDA 510(k) clearance K233190 · decided 2024-01-18
Clearance details
- K-number
- K233190
- Device name
- ENFit Adaptor
- Applicant
- Jiangsu Caina Medical Co.,Ltd
- Decision
- Substantially Equivalent
- Date received
- 2023-09-28
- Decision date
- 2024-01-18
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- PIO
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Jiangyin, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector (K231299) | Cair Lgl | 2024-01-22 |
| Enteral Transition Adaptor (K220165) | GBUK Group, Ltd. | 2022-10-21 |
| Cedic Enteral ENFit Transition Connectors (K162254) | Cedic S.R.L. | 2017-05-04 |
| Nutrisafe 2- ENFit Adaptor (K151237) | Vygon | 2016-02-09 |
| Medline ENFit Connectors (K151628) | Medline Industries, Inc. | 2015-07-24 |
| AMT Enteral Transition Adapters (K150034) | Applied Medical Technology, Inc. | 2015-06-09 |
| Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port (K150010) | Cedic S.R.L. | 2015-04-02 |
| CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT (K140581) | Cedic S.R.L. | 2014-10-17 |
Recalls involving this device
No recalls on record reference this clearance.