DURAGEN XS DURAL REGENERATION MATRIX— 510(k) K072207
Substantially EquivalentIntegra Lifesciences Corp.
FDA 510(k) clearance K072207 for DURAGEN XS DURAL REGENERATION MATRIX, Substantially Equivalent on 2007-08-23. 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
- Special
- 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 K072207
K-number listed on FDA's recall record- Z-1285-2013 — DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGen XS is an easy to handle, soft, white, pliable, non-friable, porous collagen matrix. DuraGen XS is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes.
- Z-1286-2013 — NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072207.
Data sourced from openFDA. This site is unofficial and independent of the FDA.