# K233458: CM005 Standard (CM005); CM004 Mini (CM004)

- Pathway: 510(k) (Traditional)
- Applicant: Connexicon Medical, Ltd.
- Decided: Jul 15, 2024 after 266 days
- Product code: MPN (Tissue Adhesive For The Topical Approximation Of Skin)
- Device class: 2
- Regulation: 21 CFR 878.4010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to P960052 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152096: DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive, ETHICON, Inc. (2015) Summary page 5.

## Indications for use
The indication for use for both devices is shown below: CM005 Standard Topical Skin Adhesive is indicated for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. CM005 STANDARD Topical Skin Adhesive may be used in conjunction with, but not in place of deep dermal stitches. CM005 STANDARD Topical Skin Adhesive should be applied by trained medical or nursing staff. CMOO4 Mini Topical Skin Adhesive is indicated for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. CM004 Mini Topical Skin Adhesive may be used in conjunction with, but not in place of deep dermal stitches. CM004 Mini Topical Skin Adhesive should be applied by trained medical or nursing staff.

Source page: https://510kreport.com/device/K233458
Methodology: https://510kreport.com/methodology