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On-Gard Cord-Caddy

by On-Gard Systems, Inc.

510(k) K903855

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 NumberK903855 Date7 Sep 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  • Withdrawn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)

Full name
The on-Gard Cord-Caddy
510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 On-Gard Cord-Caddy is a medical device classified under product code GEI. It is designed to manage and secure cords in medical settings.

The device is supplied by On-Gard Systems, Inc. and received FDA 510(k) clearance on September 7, 1990. It is substantially equivalent to predicate devices and is intended for use in general and plastic surgery settings.

Other devices from On-Gard Systems, Inc.

Questions

AI-generated answers, 22 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 On‑Gard Cord‑Caddy used for in the operating room?

    It is designed to manage and secure cords during procedures, helping keep the surgical field organized and reducing the risk of entanglement in both general and plastic surgery settings.

  • How is the Cord‑Caddy provided to the user?

    The device is supplied directly by On‑Gard Systems, Inc., with the manufacturer’s address listed as 1900 Grant St., Suite 710, Denver, CO. It is delivered as a ready‑to‑use unit for immediate incorporation into the surgical tray.

  • Is the Cord‑Caddy sterile and intended for single‑use or reuse?

    The product data does not specify sterility or reuse status, so users should refer to the packaging labeling or contact the manufacturer to determine whether it is supplied sterile and whether it is intended for single‑use or multiple uses.

  • Are there multiple sizes or models of the Cord‑Caddy available?

    The provided information lists only the single product name “THE ON‑GARD CORD‑CADDY” without reference to different sizes or model numbers, indicating that only one configuration is currently documented.

  • What regulatory clearance does the Cord‑Caddy have?

    The device received FDA 510(k) clearance (K903855) on September 7, 1990, meaning it was found substantially equivalent to existing predicate devices and cleared for use in the indicated surgical specialties.