ENDOFLIP GASTRIC TUBE— 510(k) K110529

Substantially Equivalent

Crospon, Ltd.

FDA 510(k) clearance K110529 for ENDOFLIP GASTRIC TUBE, Substantially Equivalent on 2011-07-22. Applicant: Crospon, Ltd..

Clearance details

Applicant: Crospon, Ltd.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2011-02-24
Decision date: 2011-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, 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.