DeviceClearance

Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit— 510(k) K153347

Substantially Equivalent

Codman & Shurtleff, Inc.

FDA 510(k) clearance K153347 for Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit, Substantially Equivalent on 2016-08-19. Applicant: Codman & Shurtleff, Inc.. Device class: 2.

Clearance details

Applicant
Codman & Shurtleff, 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
Raynham, MA, US
Download summary PDFView on FDA.gov ↗

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More clearances from Codman & Shurtleff, Inc.

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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 K153347

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 K153347.

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