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InstruSafe Sterilization Container

by Summit Medical LLC

510(k) K180528

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180528↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK180528 Date16 Nov 2018ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
InstruSafe(R) Sterilization Container
510(k) Number
FDA product code
KCT
FDA applicant
Summit Medical, Inc.
Device class
Class II
Regulation
21 CFR Part 880.6850
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 InstruSafe Sterilization Container is a protective enclosure designed for the safe transport and storage of sterilized medical instruments. Classified under the nomenclature category KCT (Container, Sterilization), it ensures sterility and integrity of instruments during handling and processing.

This container is intended for use in hospital settings, providing a sterile barrier between instruments and the environment. Supplied as a reusable device, it is regulated under FDA 510K clearance (K180528) and meets MDR compliance standards. It is not MRI-safe and must be stored in a clean, dry environment to maintain sterility and functionality.

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Questions

AI-generated answers, 18 Sep 2026

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

  • What types of medical facilities or settings is the InstruSafe Sterilization Container intended for use in?

    The InstruSafe Sterilization Container is specifically designed for hospital settings. Its purpose is to provide a sterile barrier for medical instruments during transport and storage, ensuring sterility and integrity while being handled in clinical environments.

  • Is the InstruSafe Sterilization Container reusable or single-use, and how should it be maintained?

    The InstruSafe Sterilization Container is a reusable device. To maintain its sterility and functionality, it must be stored in a clean, dry environment after each use. Proper cleaning and handling are essential to preserve its protective properties.

  • Can the InstruSafe Sterilization Container be used with any type of sterilized medical instrument, or are there specific limitations?

    The container is designed as a protective enclosure for sterilized medical instruments in general, ensuring sterility and integrity during transport and storage. While it is not explicitly limited to specific instrument types, it is intended for use in hospital settings where such protection is required.

  • How is the sterility of the InstruSafe Sterilization Container maintained during storage?

    The container maintains sterility by providing a sterile barrier between instruments and the environment. To ensure continued sterility, it must be stored in a clean, dry environment, away from contaminants or moisture that could compromise its protective properties.

  • Is the InstruSafe Sterilization Container compatible with MRI machines, or are there any special handling instructions?

    The InstruSafe Sterilization Container is explicitly stated as not MRI-safe. This means it should not be placed inside an MRI scanner, and users should avoid bringing it near MRI environments unless absolutely necessary, as it could interfere with imaging or pose a risk.