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Percutaneous Introducer Set, Model 042294 and Kit Model 3550-18

by Medamicus, Inc.

510(k) K013120

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 NumberK013120 Date24 Jan 2002ClearedStatusActive

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  • Withdrawn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
GZB
Device Class
Class II
Regulation
21 CFR Part 882.5880
Advisory Committee
Neurology
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 Percutaneous Introducer Set, Model 042294 and Kit Model 3550-18, is a single-use manual surgical instrument used for percutaneous introduction, manipulation, and removal of stimulation leads following needle entry. It consists of components such as a HDPE sheath with hub, a 304 stainless steel tapered dilator, and a 304 stainless steel guidewire directional guide with depth markings.

The device is supplied as a single-use instrument and is used in the field of Neurology. It is regulated under FDA class 2 with a regulation number of 882.5880. The device has been cleared with a Traditional clearance type and is substantially equivalent. It is stored and used in a medical setting, with specific sizes and models, including Model 042294 and Kit Model 3550-18.

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