← Product Code [MLR](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR) · K252843

# STERRAD 100NX Sterilization System with ALLClear Technology (10104) (K252843)

_Advanced Sterilization Products, Inc. · MLR · Apr 15, 2026 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR/K252843

## Device Facts

- **Applicant:** Advanced Sterilization Products, Inc.
- **Product Code:** [MLR](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR.md)
- **Decision Date:** Apr 15, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6860
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory Identification

An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR/K252843](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/MLR/K252843)

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