510(k) K132397
K132397 is an FDA 510(k) premarket notification submitted by W. L. Gore & Associates, Inc. for the device "GORE BIO-A WOUND MATRIX". The FDA issued a decision of Substantially Equivalent on May 7, 2014. The device falls under product code QSZ (Absorbable Synthetic Wound Dressing), a Class U device. W. L. Gore & Associates, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 2014
- Date Received
- August 1, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Absorbable Synthetic Wound Dressing
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type
Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.