← Product Code [LMG](/submissions/SU/subpart-e%E2%80%94surgical-devices/LMG) · N12159

# SURGICEL BRAND ABSORBABLE HEMOSTAT (N12159)

_ETHICON, Inc. · LMG · Oct 14, 1960 · General, Plastic Surgery · APPR_

**Canonical URL:** https://fda.innolitics.com/submissions/GENERAL%2C%20PLASTIC%20SURGERY/subpart-e%E2%80%94surgical-devices/LMG/N12159

## Device Facts

- **Applicant:** ETHICON, Inc.
- **Product Code:** [LMG](/submissions/SU/subpart-e%E2%80%94surgical-devices/LMG.md)
- **Decision Date:** Oct 14, 1960
- **Decision:** APPR
- **Regulation:** 21 CFR 878.4490
- **Device Class:** Class 3
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood. It is absorbable.

---

**Source:** [https://fda.innolitics.com/submissions/GENERAL%2C%20PLASTIC%20SURGERY/subpart-e%E2%80%94surgical-devices/LMG/N12159](https://fda.innolitics.com/submissions/GENERAL%2C%20PLASTIC%20SURGERY/subpart-e%E2%80%94surgical-devices/LMG/N12159)

**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
