Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OptaBlate Radiofrequency (RF) Generator System

K-Number: K250327 · 2025-04-15

ApplicantStryker Instruments
Decision Date2025-04-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OptaBlate Radiofrequency (RF) Generator System is a medical device manufactured by Stryker Instruments. It received FDA 510(k) clearance on 2025-04-15 under approval number K250327. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OptaBlate Radiofrequency (RF) Generator System?

OptaBlate Radiofrequency (RF) Generator System is a medical device that received FDA 510(k) clearance on 2025-04-15. It is manufactured by Stryker Instruments. The 510(k) number is K250327.

When was OptaBlate Radiofrequency (RF) Generator System approved by the FDA?

OptaBlate Radiofrequency (RF) Generator System received FDA 510(k) clearance on 2025-04-15, under approval number K250327.

What company makes OptaBlate Radiofrequency (RF) Generator System?

OptaBlate Radiofrequency (RF) Generator System is manufactured by Stryker Instruments.

What is the FDA product code for OptaBlate Radiofrequency (RF) Generator System?

The FDA product code for OptaBlate Radiofrequency (RF) Generator System is GEI.

Related Clinical Trials

NCT02647749 Non-invasive Mapping of Rhythm Disorders COMPLETED NCT07574918 Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis NOT_YET_RECRUITING NCT07579611 Efficacy of Spinal Cord Stimulation in Chemotherapy-Induced Peripheral Neuropathy NOT_YET_RECRUITING NCT07580560 Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study COMPLETED NCT07429214 A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF RECRUITING NCT06553625 Radiofrequency (RF) Ablation Prospective Outcomes Study for Central Nervous System - RAPID for CNS RECRUITING

Other Devices by Stryker Instruments

K172367Stryker Integrated Bipolar Cord and Tubing Sets K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement K223294SpineJack® Expansion Kit K222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000) K233300POWEReam 1/4 Drive K242266PhotonBlade 3; PhotonBlade 3 Smoke Evacuation

View all 19 devices →

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑