PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE— 510(k) K011787

Substantially Equivalent

Vidamed, Inc.

FDA 510(k) clearance K011787 for PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE, Substantially Equivalent on 2001-07-06. Applicant: Vidamed, Inc..

Clearance details

Applicant: Vidamed, Inc.
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 2001-06-08
Decision date: 2001-07-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, 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.