GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP— 510(k) K980306

Substantially Equivalent

Elscint, Inc.

FDA 510(k) clearance K980306 for GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP, Substantially Equivalent on 1998-04-02. Applicant: Elscint, Inc..

Clearance details

Applicant: Elscint, Inc.
Product code: Code LNH
Advisory panel: Radiology
Date received: 1998-01-27
Decision date: 1998-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hackensack, NJ, US

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Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.