Cleared Traditional

K001741 - RADIONICS RF DISC CATHETER ELECTRODE SYSTEM

K001741 is an FDA 510(k) clearance for RADIONICS RF DISC CATHETER ELECTRODE SYSTEM, manufactured by Radionics, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K001741 · Radionics, Inc. · Orthopedic device
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Oct 2000
Decision
137d
Days
Class 2
Risk

K001741 is an FDA 510(k) clearance for the RADIONICS RF DISC CATHETER ELECTRODE SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Radionics, Inc. (Burlington, US). The FDA issued a Cleared decision on October 23, 2000 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Radionics, Inc. devices

FDA 510(k) Submission Details - K001741

510(k) Number K001741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2000
Decision Date October 23, 2000
Days to Decision 137 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 122d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 541
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K001741.
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
K010179 · Ebi, L.P. · Feb 2001
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
K003898 · Ebi, L.P. · Jan 2001
METRX SYSTEM
K002931 · Medtronic Sofamor Danek, Inc. · Nov 2000
ENDIUS ENDOSCOPIC ACCESS SYSTEM
K002437 · Endius, Inc. · Oct 2000
KSEA PERCUTANEOUS FORAMINOSCOPY SET
K001918 · KARL STORZ Endoscopy-America, Inc. · Sep 2000
VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM
K002402 · Mitek Products · Aug 2000