STERRAD 100NX Sterilization System with ALLClear Technology (10104)
Device Facts
| Record ID | K252843 |
|---|---|
| Device Name | STERRAD 100NX Sterilization System with ALLClear Technology (10104) |
| Applicant | Advanced Sterilization Products, Inc. |
| Product Code | MLR · General Hospital |
| Decision Date | Apr 15, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6860 |
| Device Class | Class 2 |
Regulatory Classification
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.
