Cleared Traditional

GORE SMOOTHER II AND GORE BPTB (K941269) - FDA 510(k) Clearance

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

K941269 · W.L. Gore & Associates, Inc. · Orthopedic device
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May 1994
Decision
64d
Days
Class 2
Risk

K941269 is an FDA 510(k) clearance for the GORE SMOOTHER II AND GORE BPTB. 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 May 19, 1994 after a review of 64 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 K941269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1994
Decision Date May 19, 1994
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
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 K941269.
KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS
K943154 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
CURVED ROTATABLE DISPOSABLE ARTHROSCOPIC SURGERY BLADES
K941036 · Smith & Nephew, Inc. · Sep 1994
SMITH AND NEPHEW SPINE DEFLECTING FORCEPS
K940222 · Smith & Nephew, Inc. · Jun 1994
ARTHROSCOPE, DISPOSABLE
K933576 · United States Surgical, A Division of Tyco Healthc · Apr 1994
ARTHREX ARTHROSCOPE
K921119 · Arthrex, Inc. · Apr 1994
SHAVER BLADE SET
K940075 · Arthrex, Inc. · Apr 1994