Gastric Sizing Balloon Catheter— 510(k) K173355

Unknown

Cook Incorporated

FDA 510(k) clearance K173355 for Gastric Sizing Balloon Catheter, Unknown on 2017-11-17. Applicant: Cook Incorporated.

Clearance details

Applicant: Cook Incorporated
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2017-10-25
Decision date: 2017-11-17
Decision: Unknown
Clearance type: Special
Location: Bloomington, IN, US

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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.