K926038

Substantially Equivalent

FLEX-TECH BALLOON DILATOR

Applicant: Cape Tech Medical Products
Product code: KNQ
Advisory panel: Gastroenterology, Urology
Date received: 1992-12-01
Decision date: 1993-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Falmouth, MA, US

Adverse events under product code KNQ

product code KNQ

Malfunction: 1,844
Total: 1,844

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.