510(k) clearance
MEDIVATORS™ ADVANTAGE NXT™ Automated Endoscope Reprocessor
- 510(k) number
- K261791
- Applicant
- Steris
- Decision date
- Oct 2, 2026
- Date received
- May 29, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- FEB
- Device type
- Accessories, Cleaning, For Endoscope
- Device class
- Class II
- Regulation
- 21 CFR 876.1500
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Mentor, OH, US