REDFIELD INFRARED COAGULATOR— 510(k) K911648

Substantially Equivalent

Redfield Corp.

FDA 510(k) clearance K911648 for REDFIELD INFRARED COAGULATOR, Substantially Equivalent on 1991-07-11. Applicant: Redfield Corp..

Clearance details

Applicant: Redfield Corp.
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 1991-04-12
Decision date: 1991-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, D.C., DC, 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.