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Catheter Tunneler

by Gerard Medical, Inc.

510(k) K972555

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 NumberK972555 Date22 Dec 1997ClearedStatusActive

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  • Withdrawn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
LJS
Device Class
Class II
Regulation
21 CFR Part 880.5970
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

A catheter tunneler is a device used to create a subcutaneous tunnel for the placement of long-term intravascular catheters. It is classified as a Class II medical device under FDA regulation 880.5970 with product code LJS.

The device received traditional 510(k) clearance (K972555) on December 22, 1997, and is substantially equivalent to a predicate device. It is manufactured by Gerard Medical, Inc. and intended for use in general hospital settings.

Other devices from Gerard Medical, Inc.

Questions

AI-generated answers, 23 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 catheter tunneler used for?

    The catheter tunneler is used to create a subcutaneous tunnel for the placement of long-term intravascular catheters, enabling secure and stable access for therapies lasting more than 30 days.

  • Who manufactures the catheter tunneler and where are they located?

    The catheter tunneler is manufactured by Gerard Medical, Inc., located at 6 City Depot Rd., P.O. Box 940, Charlton City, MA 01508, United States.

  • What regulatory pathway was used for the catheter tunneler's market authorization?

    The device received traditional 510(k) clearance (K972555) on December 22, 1997, demonstrating substantial equivalence to a predicate device under FDA regulations.

  • What is the device classification and product code for the catheter tunneler?

    The catheter tunneler is classified as a Class II medical device under FDA regulation 880.5970 with product code LJS, indicating its use in general hospital settings for long-term vascular access.