Cleared Traditional

K090608 - MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B)

K090608 is an FDA 510(k) clearance for MINTA RYAN RF THERMOCOUPLE ELECTRODE (R..., manufactured by Minta Medical Limited. The device is a Class 2 Neurology device with product code GXI cleared through the Traditional 510(k) pathway after a 465-day FDA review.

K090608 · Minta Medical Limited · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
465d
Days
Class 2
Risk

K090608 is an FDA 510(k) clearance for the MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTER.... Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Minta Medical Limited (Knowsley Merseyside, GB). The FDA issued a Cleared decision on June 14, 2010 after a review of 465 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

FDA 510(k) Submission Details - K090608

510(k) Number K090608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2009
Decision Date June 14, 2010
Days to Decision 465 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
316d slower than avg
Panel avg: 149d · This submission: 465d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GXI Probe, Radiofrequency Lesion

All 65
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K090608.
OWL CANNULAE
K102566 · Diros Technology, Inc. · Jun 2011
OWL RF PROBES
K110593 · Diros Technology, Inc. · May 2011
DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
K101372 · Baylis Medical Co., Inc. · Aug 2010
PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS
K092337 · Baylis Medical Co., Inc. · Oct 2009
SMITH & NEPHEW RF CANNULATE
K090955 · Smith & Nephew, Inc. · Jul 2009
TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC
K080771 · Top Corp. · Nov 2008
K090608 · MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B)
Download PDF FDA Summary Minta Medical Limited