Cleared Traditional

K903412 - STORZ MODEL M705 AND/OR M706 CEILING MO...

K903412 is the FDA 510(k) clearance for STORZ MODEL M705 AND/OR M706 CEILING MO... by Storz Instrument Co.. It is a Class 1 General & Plastic Surgery device (product code EPT) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K903412 · Storz Instrument Co. · General & Plastic Surgery device
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Sep 1990
Decision
52d
Days
Class 1
Risk

K903412 is an FDA 510(k) clearance for the STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR.. Classified as Microscope, Surgical (product code EPT), Class I - General Controls.

Submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on September 20, 1990 after a review of 52 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4700 - the FDA general and plastic surgery device 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 Storz Instrument Co. devices

Submission Details

510(k) Number K903412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1990
Decision Date September 20, 1990
Days to Decision 52 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 115d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EPT Microscope, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4700
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EPT Microscope, Surgical

All 12
Devices cleared under the same product code (EPT) and FDA review panel - the closest regulatory comparables to K903412.
MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM
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OPMI CS
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STORZ DIAGNOSTIC MICROSCOPE SYSTEM
K882269 · Storz Instrument Co. · Jun 1988
ZEISS VOICE CONTROL SYSTEM FOR OPMI'S
K860811 · Carl Zeiss, Inc. · Apr 1986
STORZ/URBAN SURGICAL MICROSCOPE SYSTEM
K844858 · Storz Instrument Co. · Mar 1985
MICROSCOPE
K822561 · Treace Medical, Inc. · Sep 1982