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Sterile Pan Set

by Medi-Plast Intl., Inc.

510(k) K842136

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 NumberK842136 Date6 Jul 1984ClearedStatusActive

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  • Withdrawn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, 25 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 Sterile Pan Set is a medical device designed for hospital use. It is a sterile set that includes pans for various medical applications.

This device is supplied sterile and is intended for single-use. It is MRI safe and available in various sizes. The device has FDA 510(k) clearance with product code FRG.

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Questions

AI-generated answers, 25 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 is the Sterile Pan Set used for?

    The Sterile Pan Set is designed for hospital use and includes pans for various medical applications. It is supplied sterile and intended for single-use procedures.

  • Is the Sterile Pan Set reusable?

    No, the Sterile Pan Set is intended for single-use only. It is supplied sterile and should not be reused to maintain sterility and prevent cross-contamination.

  • What sizes are available for the Sterile Pan Set?

    The Sterile Pan Set is available in various sizes to accommodate different medical applications. Specific size options should be confirmed with the manufacturer.

  • Is the Sterile Pan Set MRI safe?

    Yes, the Sterile Pan Set is MRI safe, making it suitable for use in MRI environments where non-MRI compatible devices would pose safety risks.

  • What regulatory approvals does the Sterile Pan Set have?

    The Sterile Pan Set has FDA 510(k) clearance with product code FRG. It was determined to be substantially equivalent to predicate devices through the traditional clearance process.