Cleared Traditional

K090136: STERIS CMAX XLT SURGICAL TABLE

K090136 · STERIS Corporation · General & Plastic Surgery
Mar 2009
Decision
58d
Days
Class 1
Risk

About This 510(k) Submission

K090136 is an FDA 510(k) clearance for the STERIS CMAX XLT SURGICAL TABLE, a Table, Operating-room, Ac-powered (Class I — General Controls, product code FQO), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on March 20, 2009, 58 days after receiving the submission on January 21, 2009. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number K090136 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 2009
Decision Date March 20, 2009
Days to Decision 58 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FQO — Table, Operating-room, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4960