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STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle - APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)
FDA 510(k)Class II (US FDA 510(k))
510(k) K234082
Identifiers
- 510(k) Number
- K234082 FDA 510(k)
- FDA Product Code
- MLR FDA 510(k)
- Models / Variants
- APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.6860 FDA 510(k)
- Regulation Number
- 880.6860 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle - APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077) by Advanced Sterilization…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K234082 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Sterilization Products
Sources (1)
- FDA 510(k) K234082 24 fields · synced Jun 19, 2026