Cleared Traditional

K844858 - STORZ/URBAN SURGICAL MICROSCOPE SYSTEM

K844858 is an FDA 510(k) clearance for STORZ/URBAN SURGICAL MICROSCOPE SYSTEM, manufactured by Storz Instrument Co.. The device is a Class 1 General & Plastic Surgery device with product code EPT cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K844858 · Storz Instrument Co. · General & Plastic Surgery device
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Mar 1985
Decision
101d
Days
Class 1
Risk

K844858 is an FDA 510(k) clearance for the STORZ/URBAN SURGICAL MICROSCOPE SYSTEM. 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 March 25, 1985 after a review of 101 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Storz Instrument Co. devices

FDA 510(k) Submission Details - K844858

510(k) Number K844858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1984
Decision Date March 25, 1985
Days to Decision 101 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
14d faster than avg
Panel avg: 115d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

EPT Device Classification - Class 1, General Controls

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 K844858.
OPMI CS
K883581 · Carl Zeiss, Inc. · Sep 1988
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K882269 · Storz Instrument Co. · Jun 1988
ZEISS VOICE CONTROL SYSTEM FOR OPMI'S
K860811 · Carl Zeiss, Inc. · Apr 1986
MICROSCOPE
K822561 · Treace Medical, Inc. · Sep 1982
NAGASHIMA SU-A CEILING MOUNT UNIT FOR
K822014 · Kelleher Corp. · Aug 1982
BINOCULAR OPERATING MICROSCOPES &
K822009 · Kelleher Corp. · Jul 1982