OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)

FDA 510(k) K250213 · Stryker Instruments

Substantially Equivalent

510(k) numberK250213

Submission

Device name
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)
Applicant
Stryker Instruments
Portage, MI, US
Received
January 24, 2025
Decision date
May 15, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GXI – Probe, Radiofrequency Lesion
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4725
Specialty
Neurology

Other 510(k)s with product code GXI

510(k)DeviceApplicantDecision
K253907Disposable Radiofrequency CannulaGXI · Traditional Abbott Medical04/16/2026SE
K251802STAR RF Ablation SystemGXI · Traditional Merit Medical Systems, Inc.02/13/2026SE
K251243OneRF Trigeminal Nerve Radiofrequency ProbesGXI · Traditional Neuroone Medical Technologies Corp.08/15/2025SE
K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)GXI · Traditional Abbott Medical05/27/2025SE
K241367RF CannulaGXI · Traditional Shanghai Samedical & Plastic Instruments Co., Ltd.01/23/2025SE
K222281Intracept Intraosseous Nerve Ablation SystemGXI · Traditional Relievant Medsystems, Inc.10/26/2022SE
K213836Intracept Intraosseous Nerve Ablation SystemGXI · Traditional Relievant Medsystems, Inc.03/11/2022SE
K203066COOLIEF Cooled Radiofrequency Kit AdvancedGXI · Traditional Avanos Medical, Inc.12/22/2020SE
K190259Vesta RF CannulaGXI · Special Biomerics02/07/2020SE
K191293LCCS VC-S RF CannulaGXI · Traditional Lccs Products Limited01/24/2020SE

More from Lccs Products Limited

510(k)DeviceDecision
K261544Hydro Irrigation SystemEOB · Traditional 06/17/2026SE
K253679Hydro Irrigation SystemGWG · Traditional 05/08/2026SE
K252282SurgiCount+ SystemPBZ · Traditional 03/16/2026SE
K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…OLO · Traditional 09/25/2025SE
K250483PhotonBlade 3; PhotonBlade 3 Smoke EvacuationGEI · Traditional 09/09/2025SE
K250327OptaBlate Radiofrequency (RF) Generator SystemGEI · Special 04/15/2025SE
K243930Sonopet iQ Ultrasonic Aspirator System (5500-050-000)LFL · Traditional 03/24/2025SE
K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleOLO · Traditional 03/21/2025SE
K250374iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round…HBE · Special 03/11/2025SE
K242834System 9 Sterile Battery ContainerKCT · Traditional 01/16/2025SE

Questions and answers

When was OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) cleared by the FDA?

OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) (K250213) received a 510(k) decision of Substantially Equivalent on May 15, 2025, 111 days after the submission was received.

What is the product code of K250213?

The FDA product code is GXI – Probe, Radiofrequency Lesion, a Class II (moderate risk) device regulated under 21 CFR 882.4725.