STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104) +1 more— 510(k) K234082
Substantially EquivalentAdvanced Sterilization Products
FDA 510(k) clearance K234082 for STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104) +1 more, Substantially Equivalent on 2024-07-05. Applicant: Advanced Sterilization Products. Device class: 2.
Clearance details
- Device name as filed
- STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104); APTIMAX Instrument Tray for ULTRA GI Cycle (011077)
- Applicant
- Advanced Sterilization Products
- Product code
- Code MLR
- Device class
- Class 2
- Regulation
- 21 CFR 880.6860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvin, CA, US
Recent devices under product code MLR
view allMore clearances from Advanced Sterilization Products
view all- K163598 — Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator
- K162007 — STERRAD NX Sterilizer
- K160818 — STERRAD® NX Sterilizer with ALLClear Technology
- K160903 — STERRAD 100NX Sterilizer with ALLClearTM Technology
- K151725 — STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
Adverse events under product code MLR
product code MLR- Malfunction
- 805
- Total
- 805
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.