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ESI Model MS-103

by Electrical Systems Div.

510(k) K885120

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 NumberK885120 Date19 Jan 1990ClearedStatusActive

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  • Withdrawn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
GZT
Device Class
Class II
Regulation
21 CFR Part 882.4800
Advisory Committee
Neurology
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.

The ESI Model MS-103 is a self-retaining retractor designed for neurosurgical procedures. It is a Class II medical device that provides surgical access and tissue retraction during neurosurgical operations.

The device is supplied by Electrical Systems Div. and received FDA 510(k) clearance with decision code SESE on January 19, 1990. It is authorized under product code GZT and is intended for use in neurology settings. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions 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 ESI Model MS-103 used for?

    The ESI Model MS-103 is a self-retaining retractor designed specifically for neurosurgical procedures. It provides surgical access and tissue retraction during neurosurgical operations, helping to maintain clear visibility of the surgical field.

  • Is the ESI Model MS-103 a single-use device or can it be reused?

    The device data does not specify whether the ESI Model MS-103 is intended for single-use or reuse. This information would need to be confirmed with the manufacturer, Electrical Systems Div., as it is not provided in the regulatory documentation.

  • What regulatory approvals does the ESI Model MS-103 have?

    The ESI Model MS-103 received FDA 510(k) clearance with decision code SESE on January 19, 1990. It is classified as a Class II medical device under product code GZT and is intended for use in neurology settings. The device was determined to be substantially equivalent to other legally marketed devices.

  • Is the ESI Model MS-103 supplied sterile?

    The device data does not provide information regarding whether the ESI Model MS-103 is supplied sterile. Sterility status would need to be confirmed with the manufacturer, Electrical Systems Div., as it is not specified in the regulatory documentation.