DeviceClearance

SELECT-A-FLOW COLLECTOR— 510(k) K810645

Substantially Equivalent

Wenmar Intl. Corp.

FDA 510(k) clearance K810645 for SELECT-A-FLOW COLLECTOR, Substantially Equivalent on 1981-05-05. Applicant: Wenmar Intl. Corp..

Clearance details

Applicant
Wenmar Intl. Corp.
Product code
Code KNX
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KNX

product code KNX
Malfunction
1,064
Total
1,064

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 →

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