AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM— 510(k) K120559
Substantially EquivalentAesculap, Inc.
FDA 510(k) clearance K120559 for AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM, Substantially Equivalent on 2012-05-24. Applicant: Aesculap, Inc.. Device class: 2.
Clearance details
- Applicant
- Aesculap, Inc.
- 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
- Center Valley, PA, US
Recent devices under product code JXG
view allMore clearances from Aesculap, Inc.
view allAdverse 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 K120559
K-number listed on FDA's recall record- Z-1012-2015 — Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
- Z-0989-2014 — Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120559.
Data sourced from openFDA. This site is unofficial and independent of the FDA.