11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT— 510(k) K992813

Substantially Equivalent

Ethicon Endo-Surgery, Inc.

FDA 510(k) clearance K992813 for 11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT, Substantially Equivalent on 1999-11-18. Applicant: Ethicon Endo-Surgery, Inc..

Clearance details

Applicant: Ethicon Endo-Surgery, Inc.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 1999-08-20
Decision date: 1999-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

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.