SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL— 510(k) K042359

Substantially Equivalent

Medical Designs, LLC

FDA 510(k) clearance K042359 for SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL, Substantially Equivalent on 2004-11-17. Applicant: Medical Designs, LLC.

Clearance details

Applicant: Medical Designs, LLC
Product code: Code JXG
Advisory panel: Neurology
Date received: 2004-08-31
Decision date: 2004-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sioux Falls, SD, 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.