Cleared Traditional

K943450 - ARTHROCARE ARTHROSCOPIC ELECTROSURGERY ...

K943450 is the FDA 510(k) clearance for ARTHROCARE ARTHROSCOPIC ELECTROSURGERY ... by Arthrocare Corp.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K943450 · Arthrocare Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 1995
Decision
238d
Days
Class 2
Risk

K943450 is an FDA 510(k) clearance for the ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Arthrocare Corp. (Mountain View, US). The FDA issued a Cleared decision on March 13, 1995 after a review of 238 days - an extended review cycle.

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 Arthrocare Corp. devices

Submission Details

510(k) Number K943450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1994
Decision Date March 13, 1995
Days to Decision 238 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
116d slower than avg
Panel avg: 122d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 360
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K943450.
BENCHMARK SERIES ARTHROSCCOPIC INSTRUMENTS
K946151 · Depuy, Inc. · May 1995
MICRO-ENDO(TM) INSTRUMENTS
K950130 · Sofamor Danek USA,Inc. · May 1995
ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMS
K941709 · Acufex Microsurgical, Inc. · Apr 1995
ARTHROSCOPE ACCESSORIES
K944210 · Stryker Endoscopy · Feb 1995
CTS RELIEF KIT
K941651 · Linvatec Corp. · Jan 1995
THE KARL STORZ ARTHROPUMP
K942298 · KARL STORZ Endoscopy-America, Inc. · Jan 1995