DeviceClearance

AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR— 510(k) K003759

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K003759 for AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR, Substantially Equivalent on 2001-06-28. Applicant: Aesculap, Inc.. Device class: 2.

Clearance details

Applicant
Aesculap, Inc.
Product code
Code GWM
Device class
Class 2
Regulation
21 CFR 882.1620
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pleasant Hill, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GWM

product code GWM
Death
21
Injury
732
Malfunction
2,063
Other
1
Total
2,817

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 K003759

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 K003759.

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