PRECISION FLOW OSV II— 510(k) K971799

Substantially Equivalent

Elekta Implants, SA

FDA 510(k) clearance K971799 for PRECISION FLOW OSV II, Substantially Equivalent on 1998-02-06. Applicant: Elekta Implants, SA.

Clearance details

Applicant: Elekta Implants, SA
Product code: Code JXG
Advisory panel: Neurology
Date received: 1997-05-15
Decision date: 1998-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coral Gables, FL, US

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Adverse events under product code JXG

product code JXG

Death: 76
Injury: 5,632
Malfunction: 2,230
Other: 4
Total: 7,942

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.