YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES— 510(k) K922821

Substantially Equivalent

Yellow Springs Instrument Co., Inc.

FDA 510(k) clearance K922821 for YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES, Substantially Equivalent on 1992-11-23. Applicant: Yellow Springs Instrument Co., Inc..

Clearance details

Applicant: Yellow Springs Instrument Co., Inc.
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 1992-06-11
Decision date: 1992-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yellow Springs, OH, US

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Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

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.