EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector
FDA 510(k) clearance K150679 · decided 2015-05-29
Clearance details
- K-number
- K150679
- Device name
- EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector
- Applicant
- Boston Scientific Corp
- Decision
- Unknown
- Date received
- 2015-03-17
- Decision date
- 2015-05-29
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- PIF
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Nu recall (Z-1551-2026) | Boston Scientific Corporation | 2026-03-11 |
| EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly recall (Z-1513-2024) | Boston Scientific Corporation | 2024-04-11 |
| EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition direct recall (Z-1514-2024) | Boston Scientific Corporation | 2024-04-11 |