← Product Code [NEU](/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU) · K082278

# MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS (K082278)

_Ethicon Endo-Sugery, LLC · NEU · Dec 16, 2008 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K082278

## Device Facts

- **Applicant:** Ethicon Endo-Sugery, LLC
- **Product Code:** [NEU](/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU.md)
- **Decision Date:** Dec 16, 2008
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4300
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K082278](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K082278)

**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:** Innolitics at https://innolitics.com
