Cleared Traditional

SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE (K960046) - FDA 510(k) Clearance

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

K960046 · Surgical Dynamics, Inc. · Orthopedic device
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Apr 1996
Decision
91d
Days
Class 2
Risk

K960046 is an FDA 510(k) clearance for the SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Surgical Dynamics, Inc. (Concord, US). The FDA issued a Cleared decision on April 2, 1996 after a review of 91 days - within the typical 510(k) review window.

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 Surgical Dynamics, Inc. devices

Submission Details

510(k) Number K960046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1996
Decision Date April 02, 1996
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
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 178
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K960046.
INSTRUMENT SET FOR ARTHROSCOPIC PERCUTANEOUS DISCECTOMY
K961713 · KARL STORZ Endoscopy-America, Inc. · May 1996
KSEA INSTRUMENTS FOR ENDOSCOPIC TREATMENT OF CARPAL TUNNEL SYNDROME
K961244 · KARL STORZ Endoscopy-America, Inc. · May 1996
ARTHOSCOPE
K960805 · United States Surgical, A Division of Tyco Healthc · Apr 1996
PERCUTANEOUS ENDOSCOPIC DISCECTOMY
K960222 · Richard Wolf Medical Instruments Corp. · Mar 1996
AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS
K954652 · Aesculap, Inc. · Feb 1996
BOZOTTA REINSERTION FORCEPS
K955480 · KARL STORZ Endoscopy-America, Inc. · Feb 1996