Cleared Traditional

AESCULAP STERILCONTAINER SYSTEM

K062510 · Aesculap · General Hospital
Nov 2006
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K062510 is an FDA 510(k) clearance for the AESCULAP STERILCONTAINER SYSTEM, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Aesculap (Center Valley, US). The FDA issued a Cleared decision on November 17, 2006, 81 days after receiving the submission on August 28, 2006. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number K062510 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2006
Decision Date November 17, 2006
Days to Decision 81 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRG — Wrap, Sterilization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6850

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