Cleared Traditional

OLYMPUS ARTHROSCOPY SYSTEM (K951354) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K951354 · Olympus America, Inc. · Orthopedic device
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Jun 1995
Decision
82d
Days
Class 2
Risk

K951354 is an FDA 510(k) clearance for the OLYMPUS ARTHROSCOPY SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Olympus America, Inc. (Lake Success, US). The FDA issued a Cleared decision on June 14, 1995 after a review of 82 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Olympus America, Inc. devices

Submission Details

510(k) Number K951354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1995
Decision Date June 14, 1995
Days to Decision 82 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 122d · This submission: 82d
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 158
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K951354.
TAKE-APART ARTHRO-SCISSORS, GASPING, BIOPSY PUNCH FORCEPS FOR ARTHROSCOPY
K955272 · KARL STORZ Endoscopy-America, Inc. · Dec 1995
UNIMAT PUMP
K953075 · KARL STORZ Endoscopy-America, Inc. · Sep 1995
CO2 ARTHROFLATOR
K953550 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ENDOSCOPIC ARTHROSCOPY PROCEDURES
K945787 · KARL STORZ Endoscopy-America, Inc. · Jun 1995
KARL STORZ KNIVES, CURETTS, HOOKS, PROBES
K945891 · KARL STORZ Endoscopy-America, Inc. · Jun 1995
KARL STORZ UNIDRIVE SHAVER, ARTHROSCOPY BLADES
K952192 · KARL STORZ Endoscopy-America, Inc. · Jun 1995