Durepair Dura Regeneration Matrix— 510(k) K161370
Substantially EquivalentMedtronic Neurosurgery
FDA 510(k) clearance K161370 for Durepair Dura Regeneration Matrix, Substantially Equivalent on 2016-11-02. Applicant: Medtronic Neurosurgery. Device class: 2.
Clearance details
- Applicant
- Medtronic Neurosurgery
- Product code
- Code GXQ
- Device class
- Class 2
- Regulation
- 21 CFR 882.5910
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Goleta, CA, US
Recent devices under product code GXQ
view allMore clearances from Medtronic Neurosurgery
view allAdverse events under product code GXQ
product code GXQ- Death
- 11
- Injury
- 446
- Other
- 1
- Total
- 458
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 K161370
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161370.
Data sourced from openFDA. This site is unofficial and independent of the FDA.