510(k) K234082
K234082 is an FDA 510(k) premarket notification submitted by Advanced Sterilization Products for the device "STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104); APTIMAX Instrument Tray for ULTRA GI Cycle (011077)". The FDA issued a decision of Substantially Equivalent on July 5, 2024. The device falls under product code MLR (Sterilizer, Chemical), a Class II device regulated under 21 CFR 880.6860. Advanced Sterilization Products has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 5, 2024
- Date Received
- December 22, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilizer, Chemical
- Device Class
- Class II
- Regulation Number
- 880.6860
- Review Panel
- HO
- Submission Type