Cleared Traditional

K003695 - MICROSCOPE-STAINLESS STEEL/FIBER OPTIC:...

K003695 is an FDA 510(k) clearance for MICROSCOPE-STAINLESS STEEL/FIBER OPTIC:..., 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 76-day FDA review.

K003695 · Micro-Medical Devices, Inc. · Orthopedic device
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Feb 2001
Decision
76d
Days
Class 2
Risk

K003695 is an FDA 510(k) clearance for the MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2..... Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Micro-Medical Devices, Inc. (Cleveland, US). The FDA issued a Cleared decision on February 14, 2001 after a review of 76 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 Micro-Medical Devices, Inc. devices

FDA 510(k) Submission Details - K003695

510(k) Number K003695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2000
Decision Date February 14, 2001
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
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 K003695.
MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION
K003740 · Aesculap, Inc. · Apr 2001
SHAVER ABLATOR
K002088 · Linvatec Corp. · Mar 2001
DYONICS CONTROL RF SYSTEM
K003572 · Smith & Nephew, Inc. · Feb 2001
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
K010179 · Ebi, L.P. · Feb 2001
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
K003898 · Ebi, L.P. · Jan 2001
METRX SYSTEM
K002931 · Medtronic Sofamor Danek, Inc. · Nov 2000