Cleared Traditional

K972846 - BMC RF CANNULA

K972846 is the FDA 510(k) clearance for BMC RF CANNULA by Baylis Medical Co., Inc.. It is a Class 2 Neurology device (product code GXI) cleared through the Traditional 510(k) pathway after a 350-day FDA review.

K972846 · Baylis Medical Co., Inc. · Neurology device
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Jul 1998
Decision
350d
Days
Class 2
Risk

K972846 is an FDA 510(k) clearance for the BMC RF CANNULA. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Baylis Medical Co., Inc. (Mississauga, CA). The FDA issued a Cleared decision on July 17, 1998 after a review of 350 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Baylis Medical Co., Inc. devices

Submission Details

510(k) Number K972846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1997
Decision Date July 17, 1998
Days to Decision 350 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
202d slower than avg
Panel avg: 148d · This submission: 350d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 36
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K972846.
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K034012 · Smith & Nephew, Inc. · Mar 2004
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20
K001588 · Arthrocare Corp. · Aug 2000
RADIONICS MICROELECTRODE KIT
K991399 · Radionics, Inc. · Sep 1999
RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS)
K980430 · Radionics, Inc. · Mar 1998
MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN
K884347 · Advanced Surgical Products, Inc. · Dec 1988
STORZ DISPOSABLE BIPOLAR PENCILS
K882802 · Storz Instrument Co. · Aug 1988