GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)— 510(k) K160654

Substantially Equivalent

Covidien, LLC

FDA 510(k) clearance K160654 for GastriSail Gastric Positioning System 40 Fr/CH (13.3mm), Substantially Equivalent on 2016-05-04. Applicant: Covidien, LLC.

Clearance details

Applicant: Covidien, LLC
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2016-03-08
Decision date: 2016-05-04
Decision: Substantially Equivalent
Clearance type: Special
Location: North Haven, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

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.