Cleared Traditional

K970642 - TENOSCOPE

K970642 is an FDA 510(k) clearance for TENOSCOPE, manufactured by Luxtec Corp.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K970642 · Luxtec Corp. · Orthopedic device
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May 1997
Decision
90d
Days
Class 2
Risk

K970642 is an FDA 510(k) clearance for the TENOSCOPE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Luxtec Corp. (Newton, US). The FDA issued a Cleared decision on May 21, 1997 after a review of 90 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 Luxtec Corp. devices

FDA 510(k) Submission Details - K970642

510(k) Number K970642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1997
Decision Date May 21, 1997
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

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 394
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K970642.
ARTHROSCOPE
K971083 · Electro-Biology, Inc. · Jun 1997
UNIVERSAL DRIVE SYSTEM
K971059 · Linvatec Corp. · Jun 1997
VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS
K971253 · Smith & Nephew, Inc. · Jun 1997
KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY
K970055 · KARL STORZ Endoscopy-America, Inc. · Mar 1997
STRYKER TEMPEST ORTHOPEDIC PUMP
K963304 · Stryker Endoscopy · Jan 1997
KARL STORZ SLOTTED WHISKER ARTHROSCOPIC BLADE
K963029 · KARL STORZ Endoscopy-America, Inc. · Nov 1996