Submission Details
| 510(k) Number | K234082 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 22, 2023 |
| Decision Date | July 05, 2024 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
STERRAD? 100NX Sterilizer with ALLClear? Technology and ULTRA GI? Cycle (10104); APTIMAX? Instrument Tray for ULTRA GI? Cycle (011077)
Jul 2024
Decision
196d
Days
Class 2
Risk
About This 510(k) Submission
K234082 is an FDA 510(k) clearance for the STERRAD? 100NX Sterilizer with ALLClear? Technology and ULTRA GI? Cycle (10104); APTIMAX? Instrument Tray for ULTRA GI? Cycle (011077), a Sterilizer, Chemical (Class II — Special Controls, product code MLR), submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on July 5, 2024, 196 days after receiving the submission on December 22, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6860.
Device Classification
| Product Code | MLR — Sterilizer, Chemical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.6860 |
Manufacturer
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