Container System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K792558 ↗

FDA Product Code

FLE

Device Class

Class II

Regulation

21 CFR Part 880.6880

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Protegraft Dv 1500, 1900 & Low Por, Unigraft Dv

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  FDA 510(k) K890182 Active Cleared 28 Feb 1990

• Resurface Proshesis

  Not classified

  FDA 510(k) K781343 Active Cleared 27 Sep 1978

• Drill, Dental

  Class I

  FDA 510(k) K801887 Active Cleared 20 Aug 1980

• Insitucat Valve Stripper

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  FDA 510(k) K885046 Active Cleared 28 Feb 1990

• Yasargil Aneurysm Clips

  Class II

  FDA 510(k) K772200 Active Cleared 8 Dec 1977

• Robotrac (Tm) Retractor Arm

  Class I

  FDA 510(k) K893121 Active Cleared 1 Jun 1989

See all devices from Aesculap Instruments Corp. →

• What is the primary purpose of the Container System?

  The Container System is designed to facilitate the sterilization of medical instruments. It functions as a steam sterilizer intended for use within a general hospital setting.

• Is this device regulated by the FDA?

  Yes, the Container System is regulated under 21 CFR 880.6880 and has received FDA 510k clearance. It is classified as a Class 2 medical device.

• What is the regulatory classification of this sterilizer?

  This device is categorized under product code FLE and is regulated as a steam sterilizer. It has been cleared through the traditional 510k process as substantially equivalent to existing devices.