Cleared Traditional

K153272 - INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set

K153272 is an FDA 510(k) clearance for INTRACEPT Flexible Bi-Polar RF Probe an..., manufactured by Relievant Medsystems. The device is a Class 2 Neurology device with product code GXI cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K153272 · Relievant Medsystems · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
240d
Days
Class 2
Risk

K153272 is an FDA 510(k) clearance for the INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Relievant Medsystems (Redwood City, US). The FDA issued a Cleared decision on July 9, 2016 after a review of 240 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4725 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Relievant Medsystems devices

FDA 510(k) Submission Details - K153272

510(k) Number K153272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2015
Decision Date July 09, 2016
Days to Decision 240 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 148d · This submission: 240d
Pathway characteristics
Predicate-based equivalence.

GXI Device Classification - Class 2, Special Controls

Product Code GXI Probe, Radiofrequency Lesion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00027352 Completed Observational NIH-sponsored

A Comparison of Two Ways to Manage Anti-HIV Treatment (The SMART Study)

A Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)

6000
Patients (est.)
127
Sites
Condition studied HIV Infections
Eligibility All sexes · 13 Years+
Principal investigator Wafaa El-Sadr, MD, MPH
Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Study completed - no results published. This trial concluded in but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - GXI Probe, Radiofrequency Lesion

All 53
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K153272.
Coolief* Cooled RF Probe
K163461 · Halyard Health, Inc. · Apr 2017
COOLIEF Cooled Radiofrequency Kit
K163236 · Halyard Health, Inc. · Dec 2016
LCCS Disposable RF Electrode, LCCS Reusable RF Electrode
K152642 · Lccs Products Limited · Aug 2016
Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH
K150371 · Diros Technology, Inc. · Jul 2015
OWL CANNULAE
K141586 · Diros Technology, Inc. · Dec 2014
STRYKER VENOM ELECTRODES AND CANNULAE
K123178 · Stryker Instruments, Instruments Div. · Mar 2013