DURAGEN DURAL GRAFT MATRIX— 510(k) K982180
Substantially EquivalentIntegra Lifesciences Corp.
FDA 510(k) clearance K982180 for DURAGEN DURAL GRAFT MATRIX, Substantially Equivalent on 1999-07-06. Applicant: Integra Lifesciences Corp.. Device class: 2.
Clearance details
- Applicant
- Integra Lifesciences Corp.
- 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
- Plainsboro, NJ, US
Recent devices under product code GXQ
view allMore clearances from Integra Lifesciences Corp.
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 K982180
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 K982180.
Data sourced from openFDA. This site is unofficial and independent of the FDA.