← Product Code [QSZ](/productcode/QSZ) · K261245

# Restrata (K261245)

_Acera Surgical, Inc. · QSZ · Oct 16, 2026 · SU · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K261245

## Device Facts

- **Applicant:** Acera Surgical, Inc.
- **Product Code:** [QSZ](/productcode/QSZ.md)
- **Decision Date:** Oct 16, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU

## Regulatory Identification

Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.

---

**Source:** [https://fda.innolitics.com/device/K261245](https://fda.innolitics.com/device/K261245)

**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