COLON-X— 510(k) K760777

Substantially Equivalent

Carlton Hygienics, Inc.

FDA 510(k) clearance K760777 for COLON-X, Substantially Equivalent on 1977-01-13. Applicant: Carlton Hygienics, Inc..

Clearance details

Applicant: Carlton Hygienics, Inc.
Product code: Code FCE
Advisory panel: Gastroenterology, Urology
Date received: 1976-10-04
Decision date: 1977-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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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.