Cleared Abbreviated

K010865 - AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY (FDA 510(k) Clearance)

K010865 · STERIS Corporation · General Hospital
May 2001
Decision
70d
Days
Class 2
Risk

K010865 is an FDA 510(k) clearance for the AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on May 31, 2001, 70 days after receiving the submission on March 22, 2001.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.

Submission Details

510(k) Number K010865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2001
Decision Date May 31, 2001
Days to Decision 70 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FLE — Sterilizer, Steam
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.6880