510(k) K161003 ยท PIF Gastrointestinal Tubes With Enteral Specific Connectors
EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Butto
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Unknown, Jun 17, 2016 |
| Received | Apr 11, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161003
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2024 | Boston Scientific Corporation EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510. Open, Classified |
PIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.