← Product Code [FZZ](/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ) · K864371 # SURGICAL SKIN MARKER (K864371) _Myocure, Inc. · FZZ · Nov 17, 1986 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K864371 ## Device Facts - **Applicant:** Myocure, Inc. - **Product Code:** [FZZ](/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ.md) - **Decision Date:** Nov 17, 1986 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4660 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery ## Regulatory Identification A skin marker is a pen-like device intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K864371](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K864371) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZZ/K864371