Renew Lead Extension

Q: What is the product code of K991784?

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) K991784 · Advanced Neuromodulation Systems

Substantially Equivalent

510(k) numberK991784

Submission

Device name: Renew Lead Extension
Applicant: Advanced Neuromodulation Systems
Allen, TX, US
Received: May 25, 1999
Decision date: June 24, 1999
Decision: Substantially Equivalent (SESE)
Type: Special 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
K092371	Swift-Lock Anchor, Model 1192GZB · Traditional	12/23/2009SE
K090907	Penta Lead Kits, Models: 3227-3234GZB · Traditional	06/02/2009SE
K081208	Cinch Anchor, Model 1194GZB · Traditional	07/18/2008SE
K072462	Wide Spaced Quattrode LeadsGZB · Special	10/11/2007SE
K070847	Trial Cable, 3009GZB · Special	04/11/2007SE
K063080	Tripole 8C and 16C and Exclaim 8 Lamitrode Series LeadsGZB · Special	12/12/2006SE
K053250	Ans 90 CM and 110 CM (3100 and 3200 Series) Lead KitGZB · Special	12/15/2005SE
K052374	Rapid Progeammer 3.0GZB · Traditional	11/22/2005SE
K052418	Axxess Butterfly AnchorGZB · Special	09/26/2005SE
K050922	Ans SCS Accessory KitGZB · Special	05/18/2005SE

Questions and answers

When was Renew Lead Extension cleared by the FDA?

Renew Lead Extension (K991784) received a 510(k) decision of Substantially Equivalent on June 24, 1999, 30 days after the submission was received.

What is the product code of K991784?

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