Cleared Traditional

K951163 - GORE SMOOTHER GUIDED RASP

K951163 is the FDA 510(k) clearance for GORE SMOOTHER GUIDED RASP by W.L. Gore & Associates, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

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
Combination Product No
PCCP Authorized No
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 379
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K951163.
KARL STORZ KNIVES, CURETTS, HOOKS, PROBES
K945891 · KARL STORZ Endoscopy-America, Inc. · Jun 1995
ACUFEX ENDOBUTTON PACK
K951859 · Acufex Microsurgical, Inc. · Jun 1995
KARL STORZ UNIDRIVE SHAVER, ARTHROSCOPY BLADES
K952192 · KARL STORZ Endoscopy-America, Inc. · Jun 1995
ARTHROSCOPIC TELESCOPES
K943052 · Karl Storz Endoscopy · May 1995
ARTHROSCOPE FOR SMALL JOINT AFTER FELDKAMP, MODEL 8871.011
K940179 · Richard Wolf Medical Instruments Corp. · May 1995
DANEK RIGID ARTHROSCOPE
K950501 · Sofamor Danek USA,Inc. · May 1995