K234082

STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104); APTIMAX Instrument Tray for ULTRA GI Cycle (011077)

510(k) number: K234082
Device name: STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104); APTIMAX Instrument Tray for ULTRA GI Cycle (011077)
Applicant: Advanced Sterilization Products CA · US
Product code: MLR — Sterilizer, Chemical
Decision date: 2024-07-05
Date received: 2023-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General Hospital

Also available from FDA: K234082.pdf

Official FDA record: K234082

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.