Cleared Traditional

Family of Steam sterilizers B17 B22 Series

K161848 · Cefla S.C. · General Hospital
Feb 2017
Decision
233d
Days
Class 2
Risk

About This 510(k) Submission

K161848 is an FDA 510(k) clearance for the Family of Steam sterilizers B17 B22 Series, a Sterilizer, Steam (Class II — Special Controls, product code FLE), submitted by Cefla S.C. (Imola (Bo), IT). The FDA issued a Cleared decision on February 23, 2017, 233 days after receiving the submission on July 5, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6880.

Submission Details

510(k) Number K161848 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2016
Decision Date February 23, 2017
Days to Decision 233 days
Submission Type Traditional
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

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