Cleared Traditional

GORE SMOOTHER GUIDED RASP (K951163) - FDA 510(k) Clearance

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

K951163 · W.L. Gore & Associates, Inc. · Orthopedic device
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Jun 1995
Decision
79d
Days
Class 2
Risk

K951163 is an FDA 510(k) clearance for the GORE SMOOTHER GUIDED RASP. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on June 1, 1995 after a review of 79 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 W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K951163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1995
Decision Date June 01, 1995
Days to Decision 79 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 122d · This submission: 79d
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 K951163.
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
KSEA DISPOSABLE TUBING SET FOR THE ARTHROPUMP
K950561 · KARL STORZ Endoscopy-America, Inc. · May 1995
BENCHMARK SERIES ARTHROSCCOPIC INSTRUMENTS
K946151 · Depuy, Inc. · May 1995
THE KARL STORZ ARTHROPUMP
K942298 · KARL STORZ Endoscopy-America, Inc. · Jan 1995