OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004— 510(k) K882474

Substantially Equivalent

Ela Medical, Inc.

FDA 510(k) clearance K882474 for OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004, Substantially Equivalent on 1988-09-12. Applicant: Ela Medical, Inc..

Clearance details

Applicant: Ela Medical, Inc.
Product code: Code DXY
Advisory panel: Cardiovascular
Date received: 1988-06-15
Decision date: 1988-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

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Adverse events under product code DXY

product code DXY

Death: 240
Injury: 2,328
Malfunction: 2,096
Total: 4,664

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.