OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004— 510(k) K882476

Substantially Equivalent

Ela Medical, Inc.

FDA 510(k) clearance K882476 for OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004, 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

Download summary PDF View on FDA.gov ↗

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.