# K212246: Exofin Precision Pen

- Pathway: 510(k) (Special)
- Applicant: Chemence Medical, Inc.
- Decided: Sep 9, 2021 after 52 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: 4 generations back to P960052 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200264: Exofin High Viscosity Topical Skin Adhesive, Chemence Medical, Inc. (2020) Summary page 4.

## Indications for use
Exofin® Precision Pen is intended 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. Exofin® Precision Pen may be used in conjunction with, but not in place of, deep dermal sutures.

Source page: https://510kreport.com/device/K212246
Methodology: https://510kreport.com/methodology