Medline ENFit Connectors
FDA 510(k) clearance K151628 · decided 2015-07-24
Clearance details
- K-number
- K151628
- Device name
- Medline ENFit Connectors
- Applicant
- Medline Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-06-17
- Decision date
- 2015-07-24
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- PIO
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mundelein, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC recall (Z-1690-2026) | Medline Industries, LP | 2026-03-27 |