Atlas FDA

AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM

FDA 510(k) clearance K120559 · decided 2012-05-24

Clearance details

K-number
K120559
Device name
AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM
Applicant
Aesculap, Inc.
Decision
Substantially Equivalent
Date received
2012-02-24
Decision date
2012-05-24
Days to decision
90 days
Clearance type
Traditional
Product code
JXG
Device class
2
Regulation number
882.5550
Medical specialty
Neurology
Advisory committee
Neurology
Location
Center Valley, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to recall (Z-1012-2015)Aesculap, Inc.2015-01-26
Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is recall (Z-0989-2014)Aesculap, Inc.2014-02-19