510(k) K171442
K171442 is an FDA 510(k) premarket notification submitted by Chemence Medical, Inc. for the device "Exofin Fusion Skin Closure System". The FDA issued a decision of Substantially Equivalent on September 25, 2017. The device falls under product code OMD (Cutaneous Tissue Adhesive With Mesh), a Class II device regulated under 21 CFR 878.4011. Chemence Medical, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 2017
- Date Received
- May 16, 2017
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cutaneous Tissue Adhesive With Mesh
- Device Class
- Class II
- Regulation Number
- 878.4011
- Review Panel
- SU
- Submission Type
For topical application only to hold closed easily approximated skin edges of wounds such as wounds from surgical incisions, including punctures from minimally invasive surgery, and simple thorough cleansed, trauma-induced lacerations. The device may be used in conjunction with, but not in place of, deep dermal sutures.