Cleared Traditional

Midmark and Ritter M9 and M11 UltraClave? Automatic Sterilizers and Ritter M9D AutoClave? Automatic Sterilizer

K163337 · Midmark Corporation · General Hospital

Aug 2017

Decision

276d

Days

Class 2

Risk

About This 510(k) Submission

K163337 is an FDA 510(k) clearance for the Midmark and Ritter M9 and M11 UltraClave? Automatic Sterilizers and Ritter M9D AutoClave? Automatic Sterilizer, a Sterilizer, Steam (Class II — Special Controls, product code FLE), submitted by Midmark Corporation (Versailles, US). The FDA issued a Cleared decision on August 31, 2017, 276 days after receiving the submission on November 28, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6880.

Submission Details

510(k) Number	K163337 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 28, 2016
Decision Date	August 31, 2017
Days to Decision	276 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF