Rapid Programmar

FDA 510(k) K030118 · Advanced Neuromodulation Systems

Substantially Equivalent

510(k) numberK030118

Submission

Device name
Rapid Programmar
Applicant
Advanced Neuromodulation Systems
Plano, TX, US
Received
January 13, 2003
Decision date
March 11, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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)DeviceApplicantDecision
K233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System…GZB · Traditional Boston Scientific Neuromodulation08/23/2024SE
K221376Nalu Neurostimulation SystemGZB · Special Boston Scientific Neuromodulation06/10/2022SE
K203547Nalu Neurostimulation SystemGZB · Traditional Boston Scientific Neuromodulation03/25/2021SE
K202274Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit…GZB · Traditional Boston Scientific Neuromodulation11/09/2020SE
K201618Nalu Neurostimulation SCS systemGZB · Special Boston Scientific Neuromodulation07/15/2020SE
K191466SandShark Injectable Anchor (SIA) SystemGZB · Traditional Stimwave Technologies, Inc.11/07/2019SE
K190960Nalu Lead Blank (50cm)GZB · Traditional Boston Scientific Neuromodulation07/11/2019SE
K182720Freedom Spinal Cord Stimulator (SCS) SystemGZB · Traditional Stimwave Technologies Incorporated03/29/2019SE
K183047Nalu Neurostimulation SystemGZB · Traditional Boston Scientific Neuromodulation03/22/2019SE
K180981Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly KitGZB · Traditional Stimwave Technologies Incorporated09/19/2018SE

More from Stimwave Technologies Incorporated

510(k)DeviceDecision
K092371Swift-Lock Anchor, Model 1192GZB · Traditional 12/23/2009SE
K090907Penta Lead Kits, Models: 3227-3234GZB · Traditional 06/02/2009SE
K081208Cinch Anchor, Model 1194GZB · Traditional 07/18/2008SE
K072462Wide Spaced Quattrode LeadsGZB · Special 10/11/2007SE
K070847Trial Cable, 3009GZB · Special 04/11/2007SE
K063080Tripole 8C and 16C and Exclaim 8 Lamitrode Series LeadsGZB · Special 12/12/2006SE
K053250Ans 90 CM and 110 CM (3100 and 3200 Series) Lead KitGZB · Special 12/15/2005SE
K052374Rapid Progeammer 3.0GZB · Traditional 11/22/2005SE
K052418Axxess Butterfly AnchorGZB · Special 09/26/2005SE
K050922Ans SCS Accessory KitGZB · Special 05/18/2005SE

Questions and answers

When was Rapid Programmar cleared by the FDA?

Rapid Programmar (K030118) received a 510(k) decision of Substantially Equivalent on March 11, 2003, 57 days after the submission was received.

What is the product code of K030118?

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