Cleared Traditional

K003198 - VULCAN TAC PROBES

K003198 is an FDA 510(k) clearance for VULCAN TAC PROBES, manufactured by Oratec Interventions, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K003198 · Oratec Interventions, Inc. · Orthopedic device
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Aug 2001
Decision
321d
Days
Class 2
Risk

K003198 is an FDA 510(k) clearance for the VULCAN TAC PROBES, MODEL 911XXX. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Oratec Interventions, Inc. (Menlo Park, US). The FDA issued a Cleared decision on August 29, 2001 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Oratec Interventions, Inc. devices

FDA 510(k) Submission Details - K003198

510(k) Number K003198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2000
Decision Date August 29, 2001
Days to Decision 321 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
199d slower than avg
Panel avg: 122d · This submission: 321d
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 414
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K003198.
REPROCESSED STRYKER ARTHROSCOPIC SHAVERS
K012635 · Alliance Medical Corp. · Nov 2001
REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES
K012536 · Sterilmed, Inc. · Nov 2001
VANGUARD REPROCESSED ARTHROSCOPIC BLADES
K012346 · Vanguard Medical Concepts, Inc. · Oct 2001
KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS
K010345 · KARL STORZ Endoscopy-America, Inc. · Aug 2001
ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWAND
K011083 · Arthrocare Corp. · Jun 2001
KSEA MINIATURE TELESCOPE AND ACCESSORIES
K010987 · KARL STORZ Endoscopy-America, Inc. · Jun 2001