ENEMA TUBE— 510(k) K832501

Substantially Equivalent

Cone Instruments, Inc.

FDA 510(k) clearance K832501 for ENEMA TUBE, Substantially Equivalent on 1983-08-31. Applicant: Cone Instruments, Inc..

Clearance details

Applicant: Cone Instruments, Inc.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 1983-07-27
Decision date: 1983-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.