AESCULAP- MEITHKE SHUNT SYSTEM— 510(k) K110206
Substantially EquivalentAesculap, Inc.
FDA 510(k) clearance K110206 for AESCULAP- MEITHKE SHUNT SYSTEM, Substantially Equivalent on 2011-10-27. 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 K110206
K-number listed on FDA's recall record- Z-0814-2015 — Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
- Z-0805-2013 — Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide Central Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) 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 K110206.
Data sourced from openFDA. This site is unofficial and independent of the FDA.