AMERSE 2— 510(k) K983947

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K983947 for AMERSE 2, Substantially Equivalent on 1998-12-04. Applicant: STERIS Corporation.

Clearance details

Applicant: STERIS Corporation
Product code: Code LRJ
Advisory panel: General Hospital
Date received: 1998-11-05
Decision date: 1998-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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Adverse events under product code LRJ

product code LRJ

Injury: 958
Total: 958

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.