← Product Code [FLE](/productcode/FLE) · K260354

# Foster Plus-22L (SNK/CE-F22) (K260354)

_Zhejiang Fomos Medical Technology Co., Ltd. · FLE · Oct 30, 2026 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K260354

## Device Facts

- **Applicant:** Zhejiang Fomos Medical Technology Co., Ltd.
- **Product Code:** [FLE](/productcode/FLE.md)
- **Decision Date:** Oct 30, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6880
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory Identification

A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.

---

**Source:** [https://fda.innolitics.com/device/K260354](https://fda.innolitics.com/device/K260354)

**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
