CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM— 510(k) K113526

Clearance details

Applicant

Medos International SARL

Product code

Code JXG

Device class

Class 2

Regulation

21 CFR 882.5550

Advisory panel

Neurology

Date received

2011-11-30

Decision date

2012-02-16

Decision

Substantially Equivalent

Clearance type

Special

Location

Raynham, MA, US

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Death

76

Injury

5,632

Malfunction

2,230

Other

4

Total

7,942

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2184-2014 — Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.Class II·Terminated·Codman & Shurtleff, Inc.·20140703
• Z-2185-2014 — Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.Class II·Terminated·Codman & Shurtleff, Inc.·20140703
• Z-2186-2014 — Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.Class II·Terminated·Codman & Shurtleff, Inc.·20140703
• Z-2187-2014 — Codman Certas - In line Valve with Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8803 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.Class II·Terminated·Codman & Shurtleff, Inc.·20140703
• Z-2188-2014 — Codman Certas - In Line Valve only with SIPHONGUARD¿ Device; Product Code: 82-8804 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.Class II·Terminated·Codman & Shurtleff, Inc.·20140703
• Z-2189-2014 — Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories; Product Code: 82-8805 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.Class II·Terminated·Codman & Shurtleff, Inc.·20140703
• Z-2190-2014 — Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Accessories; Product Code: 82-8806 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.Class II·Terminated·Codman & Shurtleff, Inc.·20140703
• Z-2191-2014 — Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8807 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.Class II·Terminated·Codman & Shurtleff, Inc.·20140703
• Z-1468-2014 — CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Unitized Catheter and Accessories 82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories 82-8804 In Line Valve only with SIPHONGUARD Device 82-8805 In Line Valve with SIPHONGUARD Device, Catheter and Accessories 82-8806 In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories 82-8807 In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories 82-8850 Certas Therapeutic Management SystemClass II·Terminated·Codman & Shurtleff, Inc.·20131213
• Z-0858-2014 — Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.Class II·Terminated·Codman & Shurtleff, Inc.·20130516
• Z-0859-2014 — Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product Code: 82-8801 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.Class II·Terminated·Codman & Shurtleff, Inc.·20130516
• Z-0860-2014 — Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.Class II·Terminated·Codman & Shurtleff, Inc.·20130516
• Z-0861-2014 — Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.Class II·Terminated·Codman & Shurtleff, Inc.·20130516
• Z-0862-2014 — Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories Product Code: 82-8805 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.Class II·Terminated·Codman & Shurtleff, Inc.·20130516
• Z-0863-2014 — Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Accessories Product Code: 82-8806 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.Class II·Terminated·Codman & Shurtleff, Inc.·20130516
• Z-0864-2014 — Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories Product Code: 82-8807 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.Class II·Terminated·Codman & Shurtleff, Inc.·20130516

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113526.