FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836
K Number: K083076
·
Decision Nov 20, 2008
Classifications
1
FEI Numbers
68
Registration Numbers
69
Same Product Code
257
Applicant Total
28
Review Days
35
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836
- K Number
- K083076
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5550
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Neurosurgery
- Date Received
- October 16, 2008
- Decision Date
- November 20, 2008
- Product Code
- JXG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JXG), ordered by most recent decision date.
Intellidrop
FDA 510(k)
FDA Class 2
·Neurology
Sophy Mini Monopressure Valve (SM1)
FDA 510(k)
FDA Class 2
·Neurology
EVAC-MRI
FDA 510(k)
FDA Class 2
·Neurology
Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology
FDA 510(k)
FDA Class 2
·Neurology
Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)
FDA 510(k)
FDA Class 2
·Neurology
External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Medtronic Neurosurgery
| K Number | Device Name | ||
|---|---|---|---|
| K243676 | Duet External Drainage and Monitoring System (EDMS) | Mar 10, 2025 | Substantially Equivalent |
| K242034 | Duet External Drainage and Monitoring System (EDMS) | Oct 24, 2024 | Substantially Equivalent |
| K212641 | StrataMR II Valves and Shunts | Sep 16, 2021 | Substantially Equivalent |
| K181622 | StrataMR guider tool | Oct 1, 2018 | Substantially Equivalent |
| K161370 | Durepair Dura Regeneration Matrix | Nov 2, 2016 | Substantially Equivalent |
| K152700 | StrataMR Valves and Shunts | Apr 7, 2016 | Substantially Equivalent |
| DEN120017 | Medtronic DUET External Drainage and Monitoring System | Aug 22, 2014 | Unknown |
| K123524 | MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM | Feb 13, 2013 | Substantially Equivalent |
| K110560 | MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER | Nov 18, 2011 | Substantially Equivalent |
| K091312 | PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM | Sep 2, 2009 | Substantially Equivalent |