MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor— 510(k) K261791
Substantially EquivalentSteris
FDA 510(k) clearance K261791 for MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor, Substantially Equivalent on 2026-10-02. Applicant: Steris. Device class: 2.
Summary
The MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor is a Steris product filed under FEB, endoscope cleaning accessories.
Class II, 21 CFR 876.1500. The General Hospital review panel handled it as a Traditional 510(k); the record lists Gastroenterology and Urology as the classification panel.
Steris filed from Mentor, Ohio. Review took 126 days (May 29 to October 2, 2026). The record doesn't list the endoscope models or reprocessing claims covered.
Clearance details
- Applicant
- Steris
- Product code
- Product code FEB
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mentor, OH, US
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More clearances from Steris
view allAdverse events under product code FEB
product code FEB- Malfunction
- 3,879
- Total
- 3,879
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.