510(k) K881218— GENT-L-KARE CLEANSING ENEMA SET

Substantially Equivalent

Geneva Laboratories, Inc.

Clearance details

Applicant: Geneva Laboratories, Inc.
Product code: Code FCE
Advisory panel: Gastroenterology, Urology
Date received: 1988-03-22
Decision date: 1988-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhorn, WI, US

Adverse events under product code FCE

product code FCE

Other: 2
Total: 2

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.