Cleared Traditional

K950093 - AMD SYSTEM WORKING CHANNEL SCOPE AND AC...

K950093 is the FDA 510(k) clearance for AMD SYSTEM WORKING CHANNEL SCOPE AND AC... by Smith & Nephew Richards, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K950093 · Smith & Nephew Richards, Inc. · Orthopedic device
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Aug 1995
Decision
217d
Days
Class 2
Risk

K950093 is an FDA 510(k) clearance for the AMD SYSTEM WORKING CHANNEL SCOPE AND ACCESSORIES. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Memphis, US). The FDA issued a Cleared decision on August 15, 1995 after a review of 217 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 Smith & Nephew Richards, Inc. devices

Submission Details

510(k) Number K950093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1995
Decision Date August 15, 1995
Days to Decision 217 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
95d slower than avg
Panel avg: 122d · This submission: 217d
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 388
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K950093.
STRYKER UNIVERSAL ACL INSTRUMENTATION SYSTEM
K951267 · Stryker Endoscopy · Sep 1995
UNIMAT PUMP
K953075 · KARL STORZ Endoscopy-America, Inc. · Sep 1995
CO2 ARTHROFLATOR
K953550 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
INTEQ TFCC REPAIR SYSTEM
K941862 · Linvatec Corp. · Aug 1995
OLYMPUS ARTHROSCOPY SYSTEM
K951354 · Olympus America, Inc. · Jun 1995
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ENDOSCOPIC ARTHROSCOPY PROCEDURES
K945787 · KARL STORZ Endoscopy-America, Inc. · Jun 1995