DeviceClearance

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. Device class: 2.

Clearance details

Applicant
Medical Designs, LLC
Product code
Code JXG
Device class
Class 2
Regulation
21 CFR 882.5550
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sioux Falls, SD, US
Download summary PDFView on FDA.gov ↗

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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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K042359

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042359.

Data sourced from openFDA. This site is unofficial and independent of the FDA.