510(k) K150679 ยท PIF Gastrointestinal Tubes With Enteral Specific Connectors
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector
| Applicant | Boston Scientific Corp, Marlborough MA, US |
| Decision | Unknown, May 29, 2015 |
| Received | Mar 17, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150679
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2026 | Boston Scientific Corporation EndoVive Safety PEG Kit;
Outer Box Material Number (UPN): M00509001;
Inner Box Material Number (UPN): M00509000; Open, Classified |
PIF | None listed |
| Apr 11, 2024 | Boston Scientific Corporation EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional mea Open, Classified |
PIF | None listed |
| Apr 11, 2024 | Boston Scientific Corporation EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional m Open, Classified |
PIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.