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

Q: What is the product code of K013120?

The FDA product code is GZB – Stimulator, Spinal-Cord, Implanted (Pain Relief), a Class II (moderate risk) device regulated under 21 CFR 882.5880.

FDA 510(k) K013120 · Medamicus, Inc.

Substantially Equivalent

510(k) numberK013120

Submission

Device name: Percutaneous Introducer Set, Model 042294 and Kit Model 3550-18
Applicant: Medamicus, Inc.
Minneapolis, MN, US
Received: September 18, 2001
Decision date: January 24, 2002
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GZB – Stimulator, Spinal-Cord, Implanted (Pain Relief)
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5880
Specialty: Neurology
Implant: Yes

Other 510(k)s with product code GZB

510(k)	Device	Applicant	Decision
K233801	Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System…GZB · Traditional	Boston Scientific Neuromodulation	08/23/2024SE
K221376	Nalu Neurostimulation SystemGZB · Special	Boston Scientific Neuromodulation	06/10/2022SE
K203547	Nalu Neurostimulation SystemGZB · Traditional	Boston Scientific Neuromodulation	03/25/2021SE
K202274	Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit…GZB · Traditional	Boston Scientific Neuromodulation	11/09/2020SE
K201618	Nalu Neurostimulation SCS systemGZB · Special	Boston Scientific Neuromodulation	07/15/2020SE
K191466	SandShark Injectable Anchor (SIA) SystemGZB · Traditional	Stimwave Technologies, Inc.	11/07/2019SE
K190960	Nalu Lead Blank (50cm)GZB · Traditional	Boston Scientific Neuromodulation	07/11/2019SE
K182720	Freedom Spinal Cord Stimulator (SCS) SystemGZB · Traditional	Stimwave Technologies Incorporated	03/29/2019SE
K183047	Nalu Neurostimulation SystemGZB · Traditional	Boston Scientific Neuromodulation	03/22/2019SE
K180981	Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly KitGZB · Traditional	Stimwave Technologies Incorporated	09/19/2018SE

More from Stimwave Technologies Incorporated

510(k)	Device	Decision
K040150	Modification to Medamicus Flowguard Peelable IntroducerDYB · Special	02/18/2004SE
K030905	Medamicus Flowguard Peelable IntroducerDYB · Special	04/09/2003SE
K022689	Modification to Medamicus Axia RSNDYB · Special	08/23/2002SE
K021004	Valved Peelable IntroducerDYB · Traditional	06/06/2002SE
K020563	Medamicus Axia RSNDYB · Traditional	05/21/2002SE
K011085	Guidewire Introducer Safety NeedleDYB · Traditional	07/09/2001SE
K000824	Percutaneous Introducer, Model 10383-XXXDYB · Special	04/13/2000SE
K994097	Medamicus Epidural IntroducerGZB · Traditional	03/01/2000SE
K990705	Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator SetDYB · Traditional	06/28/1999SE
K965167	Percutaneous Venous Introducer 10264DYB · Traditional	07/25/1997SE

Questions and answers

When was Percutaneous Introducer Set, Model 042294 and Kit Model 3550-18 cleared by the FDA?

Percutaneous Introducer Set, Model 042294 and Kit Model 3550-18 (K013120) received a 510(k) decision of Substantially Equivalent on January 24, 2002, 128 days after the submission was received.

What is the product code of K013120?

The FDA product code is GZB – Stimulator, Spinal-Cord, Implanted (Pain Relief), a Class II (moderate risk) device regulated under 21 CFR 882.5880.