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Stat-Mat Minor

by Macpherson Medical, Inc.

510(k) K110500

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 NumberK110500 Date23 Jun 2011ClearedStatusActive

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  • Withdrawn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
KCT
Device Class
Class II
Regulation
21 CFR Part 880.6850
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

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

STAT-MAT MINOR is a medical device classified under product code KCT for general hospital use. It is a substantially equivalent device to predicate devices including Polyvac's Surgical Instrument Delivery Systems and Riley Medical, Inc.'s MetaPak Multipurpose Instrument Tray.

The device is supplied by Macpherson Medical, Inc. and received FDA 510(k) clearance on June 23, 2011. It is a Class II medical device regulated under number 880.6850. No information regarding sterility, single-use status, MRI safety, or sizes is provided in the data.

Questions

AI-generated answers, 28 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 STAT-MAT MINOR device used for?

    The STAT-MAT MINOR is a medical device classified under product code KCT for general hospital use. It is substantially equivalent to predicate devices including Polyvac's Surgical Instrument Delivery Systems and Riley Medical, Inc.'s MetaPak Multipurpose Instrument Tray.

  • What is the regulatory status of the STAT-MAT MINOR?

    The STAT-MAT MINOR received FDA 510(k) clearance on June 23, 2011, as a Class II medical device regulated under number 880.6850. It is classified as substantially equivalent to predicate devices.

  • Who manufactures the STAT-MAT MINOR and where is it supplied from?

    The STAT-MAT MINOR is manufactured and supplied by Macpherson Medical, Inc., located at 555 13th St., NW, Columbia Sq., Washington D.C., 20004, US.

  • Is the STAT-MAT MINOR sterile or single-use?

    The provided device data does not include information regarding sterility or single-use status of the STAT-MAT MINOR. This information would need to be obtained directly from the manufacturer or product documentation.