ENDODYNAMIC SIEGEL SPHINCTEROTOME— 510(k) K853680

Substantially Equivalent

E-Z-Em, Inc.

FDA 510(k) clearance K853680 for ENDODYNAMIC SIEGEL SPHINCTEROTOME, Substantially Equivalent on 1985-11-04. Applicant: E-Z-Em, Inc..

Clearance details

Applicant: E-Z-Em, Inc.
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 1985-09-04
Decision date: 1985-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westbury, NY, US

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Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

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.