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Aesculap Sterilcontainer S

by Aesculap

510(k) K093649

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK093649 Date11 May 2010ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
FRG
Device class
Class II
Regulation
21 CFR Part 880.6850
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Aesculap SterilContainer System S is a reusable rigid container system designed for the packaging, transportation, and storage of instruments prior to, during, and after sterilization. It is part of Aesculap's range of sterile container systems, which includes containers, baskets, and accessories to meet reprocessing requirements.

The system is reusable and intended for use in sterile processing environments. It is supplied in a sterile state and is compatible with standard sterilization processes. The device is regulated under FDA 510(k) clearance, with a decision of Substantially Equivalent, and is reviewed by the General Hospital advisory committee.

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