EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector— 510(k) K150679

Unknown

Boston Scientific Corp

FDA 510(k) clearance K150679 for EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector, Unknown on 2015-05-29. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code PIF
Advisory panel: Gastroenterology, Urology
Date received: 2015-03-17
Decision date: 2015-05-29
Decision: Unknown
Clearance type: Traditional
Location: Marlborough, MA, US

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Adverse events under product code PIF

product code PIF

Death: 13
Injury: 122
Other: 1
Total: 136

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.