Cleared Traditional

K936213 - ARTHROSCOPES AND ACCESSORIES

K936213 is an FDA 510(k) clearance for ARTHROSCOPES AND ACCESSORIES, manufactured by Micro-Medical Devices, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K936213 · Micro-Medical Devices, Inc. · Orthopedic device
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May 1994
Decision
140d
Days
Class 2
Risk

K936213 is an FDA 510(k) clearance for the ARTHROSCOPES AND ACCESSORIES. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Micro-Medical Devices, Inc. (Castle Pines Village, US). The FDA issued a Cleared decision on May 18, 1994 after a review of 140 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 Micro-Medical Devices, Inc. devices

FDA 510(k) Submission Details - K936213

510(k) Number K936213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1993
Decision Date May 18, 1994
Days to Decision 140 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
18d slower than avg
Panel avg: 122d · This submission: 140d
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 K936213.
ARTHROSCOPE
K940090 · Richard Wolf Medical Instruments Corp. · Jun 1994
POLY BLADES
K940515 · Linvatec Corp. · May 1994
GORE SMOOTHER II AND GORE BPTB
K941269 · W.L. Gore & Associates, Inc. · May 1994
ACUFEX LINEAR/ROTARY INSTRUMENTS
K940981 · Acufex Microsurgical, Inc. · May 1994
ACUFEX(R) ARTHROPLASTY INSTRUMENTS
K940985 · Acufex Microsurgical, Inc. · May 1994
ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS
K941364 · Acufex Microsurgical, Inc. · May 1994