DeviceClearance

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 Button Decompression Tube with ENFit Connector— 510(k) K161003

Unknown

Boston Scientific Corporation

FDA 510(k) clearance K161003 for 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 Button Decompression Tube with ENFit Connector, Unknown on 2016-06-17. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant
Boston Scientific Corporation
Product code
Code PIF
Device class
Class 2
Regulation
21 CFR 876.5980
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Unknown
Clearance type
Traditional
Location
Marlboro, MA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code PIF

view all

More clearances from Boston Scientific Corporation

view all

Adverse events under product code PIF

product code PIF
Death
13
Injury
122
Other
1
Total
136

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

Recalls naming K161003

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161003.

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