510(k) K233460
K233460 is an FDA 510(k) premarket notification submitted by Connexicon Medical , Ltd. for the device "CM00622 LINC Skin Closure System (CM00622 LINC)". The FDA issued a decision of Substantially Equivalent on July 15, 2024. The device falls under product code OMD (Cutaneous Tissue Adhesive With Mesh), a Class II device regulated under 21 CFR 878.4011. Connexicon Medical , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 15, 2024
- Date Received
- October 23, 2023
- Clearance Type
- Traditional
- 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.