Cleared Traditional

K972846 - BMC RF CANNULA

K972846 is an FDA 510(k) clearance for BMC RF CANNULA, manufactured by Baylis Medical Co., Inc.. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K972846

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
Combination Product No
PCCP Authorized No
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.

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 59
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K972846.
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20
K001588 · Arthrocare Corp. · Aug 2000
NEUROTHERM RF CANNULA
K994344 · Rocket Medical Plc · Mar 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